Medical device recalls: July 2020

The FDA posted 74 medical device recall records in July 2020, from 15 recall events by 14 companies. 38 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

Shanghai United Imaging Healthcare Co., Ltd. · 2 events, 4 records
CME America, LLC · 1 event, 37 records, 37 Class I
Becton Dickinson & Company · 1 event, 12 records
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 1 event, 9 records
DiaSorin Molecular LLC · 1 event, 3 records
Djo, LLC · 1 event, 1 record
Edwards Lifesciences, LLC · 1 event, 1 record
Mako Surgical Corporation · 1 event, 1 record

FDA root cause

Device Design · 41
Process control · 14
Software design · 11
Under Investigation by firm · 5
Software Design Change · 1
Process design · 1
Process change control · 1

Class I recalls (38)

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

BodyGuard BodySet, REF: A120-160SAS ↗Class I
Z-2553-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A120-160XPS ↗Class I
Z-2554-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A100-163XESV ↗Class I
Z-2555-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A100-163XES ↗Class I
Z-2556-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A120-161XPS ↗Class I
Z-2557-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A120-160XSFK ↗Class I
Z-2558-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A120-112XSFK ↗Class I
Z-2559-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A100-163XSFL ↗Class I
Z-2560-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A120-160XYSF ↗Class I
Z-2561-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A120-161XYB ↗Class I
Z-2562-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A120-161XYBS ↗Class I
Z-2563-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset with Filter, REF: A100-163XESF ↗Class I
Z-2564-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A120-161XPSV ↗Class I
Z-2565-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A120-160X2YB ↗Class I
Z-2566-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY ↗Class I
Z-2567-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
CMExpress Microbore Set, REF: A120-160CRV ↗Class I
Z-2568-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
CMExpress Microbore Set, REF: A120-161CYF ↗Class I
Z-2569-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS ↗Class I
Z-2570-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset with Filter, REF: A120-160XSFE ↗Class I
Z-2571-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset with Filter, REF: A100-164XESF ↗Class I
Z-2572-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A100-163XE90S ↗Class I
Z-2573-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A100-163XSL ↗Class I
Z-2574-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A120-003XS2YV ↗Class I
Z-2575-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A120-125XSE ↗Class I
Z-2576-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset, REF: A120-160GCFA ↗Class I
Z-2577-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
CMExpress Microbore Sets, REF: A120-160CYFRV ↗Class I
Z-2578-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
CMExpress Microbore Sets, REF: A120-160C2YRV ↗Class I
Z-2579-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
CMExpress Microbore Sets, REF: A120-161C ↗Class I
Z-2580-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF ↗Class I
Z-2581-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard set with Female Luer, REF: A120-003XSN ↗Class I
Z-2582-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV ↗Class I
Z-2583-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF ↗Class I
Z-2584-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
Standard BodySet with Needleless Connectors, REF: A120-125XS ↗Class I
Z-2585-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
CMExpress Microbore Set, REF: A120-160C ↗Class I
Z-2586-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK ↗Class I
Z-2587-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset With Female Luer, REF: A120-160XPSN ↗Class I
Z-2588-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV ↗Class I
Z-2589-2020 · CME America, LLC · posted Jul 15, 2020 · Terminated
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System ↗Class I
Z-2476-2020 · Verathon, Inc. · posted Jul 10, 2020 · Terminated
When video laryngoscopy system users apply, twisting motions while connecting the blade in the HDMI port, or excessive torsion to the connection port, this force is transferred to the HDMI PCB, which may result in video synchronization interruption, loss…

Class II recalls (36)

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

Mako Hip End Effector, Variable AngleClass II
Z-2745-2020 · Mako Surgical Corporation · posted Jul 31, 2020 · Terminated
Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
Computed Tomography X-ray SystemClass II
Z-2703-2020 · Shanghai United Imaging Healthcare Co., Ltd. · posted Jul 27, 2020 · Open, Classified
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Computed Tomography X-ray SystemClass II
Z-2704-2020 · Shanghai United Imaging Healthcare Co., Ltd. · posted Jul 27, 2020 · Open, Classified
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Computed Tomography X-ray SystemClass II
Z-2705-2020 · Shanghai United Imaging Healthcare Co., Ltd. · posted Jul 27, 2020 · Open, Classified
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set… ↗Class II
Z-2706-2020 · Richard Wolf GmbH · posted Jul 27, 2020 · Terminated
Tube material of a smaller diameter was used.
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical…Class II
Z-2702-2020 · Smith & Nephew, Inc. · posted Jul 24, 2020 · Open, Classified
The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036Class II
Z-2641-2020 · Shanghai United Imaging Healthcare Co., Ltd. · posted Jul 20, 2020 · Open, Classified
Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle…
PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access SystemClass II
Z-2660-2020 · Becton Dickinson & Company · posted Jul 20, 2020 · Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A…
PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access KitClass II
Z-2661-2020 · Becton Dickinson & Company · posted Jul 20, 2020 · Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A…
PowerLoc MAX Power Injectable Infusion Port Access KitClass II
Z-2662-2020 · Becton Dickinson & Company · posted Jul 20, 2020 · Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A…
PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access KitClass II
Z-2663-2020 · Becton Dickinson & Company · posted Jul 20, 2020 · Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A…
SafeStep Huber Needle Set AllPoints Port Access SystemClass II
Z-2664-2020 · Becton Dickinson & Company · posted Jul 20, 2020 · Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A…
SafeStep Huber Needle Set myPICK Port Access KitClass II
Z-2665-2020 · Becton Dickinson & Company · posted Jul 20, 2020 · Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A…
SafeStep Huber Needle Set Port Access KitClass II
Z-2666-2020 · Becton Dickinson & Company · posted Jul 20, 2020 · Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A…
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic DressingClass II
Z-2667-2020 · Becton Dickinson & Company · posted Jul 20, 2020 · Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A…
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access KitClass II
Z-2668-2020 · Becton Dickinson & Company · posted Jul 20, 2020 · Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A…
SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection CapClass II
Z-2669-2020 · Becton Dickinson & Company · posted Jul 20, 2020 · Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A…
PowerLoc MAX Power Injectable Infusion SetClass II
Z-2670-2020 · Becton Dickinson & Company · posted Jul 20, 2020 · Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A…
SafeStep Huber Needle SetClass II
Z-2671-2020 · Becton Dickinson & Company · posted Jul 20, 2020 · Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A…
This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP -… ↗Class II
Z-2590-2020 · Djo, LLC · posted Jul 13, 2020 · Terminated
The device accessories were not labeled with appropriate latex warning.
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181 ↗Class II
Z-2007-2020 · Edwards Lifesciences, LLC · posted Jul 10, 2020 · Terminated
Sterile catheter kit packaging compromised.
CareLink SmartSync Device Manager, Model Number 24970AClass II
Z-2505-2020 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Jul 10, 2020 · Open, Classified
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check",…
Patient Connector, Model Number 24967Class II
Z-2506-2020 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Jul 10, 2020 · Open, Classified
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check",…
Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01Class II
Z-2507-2020 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Jul 10, 2020 · Open, Classified
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check",…
Azure S DR MRI, Model Number W3DR01Class II
Z-2508-2020 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Jul 10, 2020 · Open, Classified
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check",…
Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01Class II
Z-2509-2020 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Jul 10, 2020 · Open, Classified
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check",…
Azure S SR MRI, Model Number W3SR01Class II
Z-2510-2020 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Jul 10, 2020 · Open, Classified
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check",…
Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04Class II
Z-2511-2020 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Jul 10, 2020 · Open, Classified
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check",…
Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05Class II
Z-2512-2020 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Jul 10, 2020 · Open, Classified
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check",…
Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06Class II
Z-2513-2020 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Jul 10, 2020 · Open, Classified
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check",…
EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose. ↗Class II
Z-2523-2020 · Philips North America, LLC · posted Jul 10, 2020 · Terminated
Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.
VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare…Class II
Z-2537-2020 · Vitalconnect Inc. · posted Jul 10, 2020 · Terminated
A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but no notification was found. A software defect was encountered causing the lack of notification.…
MOL2150 Simplexa HSV 1&2 DirectClass II
Z-2547-2020 · DiaSorin Molecular LLC · posted Jul 10, 2020 · Terminated
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative… ↗Class II
Z-2548-2020 · DiaSorin Molecular LLC · posted Jul 10, 2020 · Terminated
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the… ↗Class II
Z-2549-2020 · DiaSorin Molecular LLC · posted Jul 10, 2020 · Terminated
Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source… ↗Class II
Z-2497-2020 · Ra Medical Systems, Inc. · posted Jul 4, 2020 · Terminated
A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.

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.