Allura Xper FD recallZ-0416-2022 · Philips North America Llc · initiated Nov 19, 2021

Why it was recalled

Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention.

FDA root cause category: Other

What the company is doing

Philips issued Medical Device Correction letter to US consignees on 19-Nov-2021. Letters outside of the U.S.A. will be distributed through the Philips Markets Organization. Letter states reason for recall, health risk and action to take: Move the MCS with a 7th or 8th monitor only before or after a procedure. " Do not position the MCS above the patient/sterile field during the procedure. " Place this Field Safety Notice with the system documentation until your system has been fixed. " Circulate this notice to all users of this device so they are aware of the product issues. " Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Field Safety Notice. A Philips representative will secure the set of screws of all affected systems. You will be contacted by your local Philips representative to schedule the service. If you need any further information, please contact your local Philips representative (reference to FC072200488).

Recall details

Recall number

Z-0416-2022

Status

Terminated

Initiated by the company

Nov 19, 2021

Recalling firm

Philips North America Llc

Quantity

USA: 5 systems R.O.W.: 15 systems

Product code

OWB

FDA submissions

K141979, K130842, K161563

Distribution

Worldwide distribution - US Nationwide distribution in the states of DC, GA, MA, TX, VA and the countries of Dominican Republic, INDIA, Japan, Poland, Spain, Taiwan.

Product description

Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

• Allura Xper FD Allura Xper FD20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  25 recalls2 deaths3,984 reports
• Allura Xper FD Allura Xper FD20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  23 recalls2 deaths3,614 reports
• Allura Xper FD Allura Xper FD10

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  23 recalls2 deaths2,015 reports
• Allura Xper FD Allura Xper FD10

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  20 recalls2 deaths1,837 reports
• Allura Xper FD Allura Xper FD10/10

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  19 recalls603 reports
• Interventional Workspot Interventional Workspot - 1

  Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological
  13 recalls24 reports

Product lines

• Allura Xper FDPhilips Medical Systems Nederland B.V. · 19 models · 15,187 reports · 84 recalls