Medical device recalls: February 2019

The FDA posted 99 medical device recall records in February 2019, from 15 recall events by 15 companies. 24 are Class I, the most serious category.

Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.

Companies with the most recall events

Philips Medical Systems Nederlands · 1 event, 64 records
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · 1 event, 13 records, 13 Class I
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 1 event, 7 records, 7 Class I
Zimmer Biomet Spine Inc. · 1 event, 3 records
Physio-Control Inc · 1 event, 2 records, 2 Class I
Alcon Research Laboratories Ltd. · 1 event, 1 record
Arjohuntleigh Magog · 1 event, 1 record
Bard Medical Division · 1 event, 1 record

FDA root cause

Unknown/Undetermined by firm · 64
Process control · 13
Component design/selection · 8
Nonconforming Material/Component · 4
Device Design · 4
Software design · 3
Under Investigation by firm · 2
Vendor change control · 1

Class I recalls (24)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

LIFEPAK 15 Monitor/DefibrillatorClass I
Z-0862-2019 · Physio-Control Inc · posted Feb 26, 2019 · Terminated
Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and…
LIFEPAK 15 Monitor/Defibrillator service kitsClass I
Z-0863-2019 · Physio-Control Inc · posted Feb 26, 2019 · Terminated
Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and…
icumedical ChemoLock Vial Spike, 20mm, REF CL-80SClass I
Z-0805-2019 · ICU Medical, Inc. · posted Feb 22, 2019 · Terminated
There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD):Class I
Z-0806-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that…
Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR):Class I
Z-0807-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that…
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD):Class I
Z-0808-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that…
Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD):Class I
Z-0809-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that…
Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR):Class I
Z-0810-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that…
Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01Class I
Z-0811-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that…
vitatron (implantable pulse generator): ↗Class I
Z-0812-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Feb 14, 2019 · Open, Classified
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that…
Portex 350 ml Sterile Water Humidifier w/5psi Adapt. ↗Class I
Z-0710-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Portex 550 ml Sterile Water Humidifier w/5psi Adapt. ↗Class I
Z-0711-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Portex 1000 ml Sterile Water USP Pour Bottle ↗Class I
Z-0712-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Portex 500 ml Sterile Water USP Pour Bottle ↗Class I
Z-0713-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt. ↗Class I
Z-0714-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Portex 550 ml Sterile Water Humidifier w/5psi Adapt. ↗Class I
Z-0715-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Intermed 550 ml Sterile Water Humidifier w/5psi Adapt. ↗Class I
Z-0716-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt. ↗Class I
Z-0717-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Medline Prefilled 350 ml Sterile ↗Class I
Z-0718-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Portex Unit Dose 5 ml Normal Saline (0.9%) ↗Class I
Z-0719-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Portex Unit Dose 15 ml Normal Saline ↗Class I
Z-0720-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Portex 5ml Normal Saline (0.9%) Unit Dose ↗Class I
Z-0721-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Medline Prefilled 550 ml Sterile ↗Class I
Z-0722-2019 · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · posted Feb 4, 2019 · Terminated
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
CoaguChek XS PT Test ↗Class I
Z-0787-2019 · Terrific Care LLC · posted Feb 1, 2019 · Terminated
Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customers who purchased products directly from Terrific Care LLC dba MedEx Supply via website/telephone/facsimile.

Class II recalls (73)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Alcon or Endure Ophthalmic Microscope ↗Class II
Z-0961-2019 · Alcon Research Laboratories Ltd. · posted Feb 27, 2019 · Terminated
Potential for the optical head to detach from the stand due to the lack of thread adhesive.
The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging SystemClass II
Z-0939-2019 · Merge Healthcare, Inc. · posted Feb 25, 2019 · Terminated
Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable limits in earth leakage current, touch current in a single fault…
Vitality Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is…Class II
Z-0866-2019 · Zimmer Biomet Spine Inc. · posted Feb 22, 2019 · Terminated
The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications
Vitality Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is…Class II
Z-0867-2019 · Zimmer Biomet Spine Inc. · posted Feb 22, 2019 · Terminated
The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications
Vitality Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw…Class II
Z-0868-2019 · Zimmer Biomet Spine Inc. · posted Feb 22, 2019 · Terminated
The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications
Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0869-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0870-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0871-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0872-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Multiva 1.5T 16 R5, Model Number 781078. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0873-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera 0.5T Standard, Model Number 781101. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0874-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0875-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0876-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0877-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0878-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0879-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera 1.5T CV, Model Number 781107. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0880-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0881-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0882-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0883-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0884-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0885-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0886-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0887-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0888-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0889-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0890-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0891-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0892-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0893-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0894-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0895-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0896-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0897-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0898-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0899-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0900-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Ingenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0901-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0902-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0903-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Ingenia 3.0T CX, Model Number 781271. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0904-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0905-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 3.0T TX-series, Model Number 781278. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0906-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0907-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Intera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0908-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0909-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0910-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0911-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0912-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 3.0T X, Model Number 781344. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0913-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0914-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0915-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Ingenia 1.5T S, Model Number 781347. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0916-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0917-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0918-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0919-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Ingenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0920-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Ingenia Ambition X, Model Number 781356. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0921-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Ingenia Elition S, Model Number 781357. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0922-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0923-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0924-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
MR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0925-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0926-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0927-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0928-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
NZM101 Ingenia 1.5T Linac, Model Number 781483. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0929-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
MARLIN 1.5T, Model Number 781474. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0930-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0931-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Multiva 1.5T, Model Number 781076. Nuclear Magnetic Resonance Imaging System ↗Class II
Z-0932-2019 · Philips Medical Systems Nederlands · posted Feb 22, 2019 · Terminated
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Naera Hospital Bassinet, Model No. 4402 ↗Class II
Z-0813-2019 · Stryker Medical Division of Stryker Corporation · posted Feb 7, 2019 · Terminated
It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed which identified…
Revolution CT systems with the SmartStep OptionClass II
Z-0776-2019 · GE Healthcare, LLC · posted Feb 6, 2019 · Open, Classified
On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was…
SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M,… ↗Class II
Z-0803-2019 · Bard Medical Division · posted Feb 6, 2019 · Terminated
potential for urine leakage around the vent on the vented sample port
ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800 ↗Class II
Z-0802-2019 · Arjohuntleigh Magog · posted Feb 5, 2019 · Terminated
Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute to a life-threatening event.

Class III recalls (2)

Using the device is not likely to cause health problems, but it violates FDA rules.

Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018Class III
Z-0822-2019 · Luminex Corporation · posted Feb 11, 2019 · Terminated
On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878Class III
Z-0792-2019 · Becton, Dickinson and Company, BD Biosciences · posted Feb 1, 2019 · Terminated
A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows 10 OS is not a released configuration for clinical use. It is released for…

Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.