Azurion recallZ-0471-2022 · Philips North America Llc · initiated Nov 12, 2021

Why it was recalled

(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available

FDA root cause category: Software design

What the company is doing

Philips issued Field Safety Notice on 11/12/21 U.S.A, Customer notified via certified mailing from the United States Postal Service (USPS). 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: Start-up problem: If the start-up problem occurs, perform a Cold Restart* of the system. b) Emergency stop recovery problem: If the emergency stop recovery problem occurs, perform a new Warm Restart* of the system. c) Place this Field Safety Notice with the documentation of the system until Philips has installed a software update in your system. d) Circulate this notice to all users of this device so they are aware of the product issues. e) Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Field Safety Notice. * The system restart options are described in section 4.2 of the Instructions for Use. 5. Describe the actions planned by Philips IGT Systems to correct these problems: These problems will be resolved by a software update (available in November 2021). You will be contacted by your local Philips representative to schedule the update of your system. If you need any further information, please contact your local Philips representative (reference to FC072200502).

Recall details

Recall number

Z-0471-2022

Status

Terminated

Initiated by the company

Nov 12, 2021

Recalling firm

Philips North America Llc

Quantity

10 units (1 US and 9 OUS)

Product code

OWB

FDA submissions

K181830

Distribution

Worldwide distribution - US Nationwide distribution in the state of WA and the countries of France, Germany, Japan, Poland, United Kingdom.

Product description

Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224

Devices named in this recall

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

• Azurion Azurion 7 M20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  32 recalls2 deaths2,308 reports
• Azurion Azurion 7 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls2 deaths1,087 reports
• Azurion Azurion 7 B20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls1 death634 reports
• Azurion Azurion 7 B20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls594 reports
• Azurion Azurion 5 M20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls201 reports
• Azurion Azurion 7 B12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  23 recalls232 reports
• Azurion Azurion 3 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  20 recalls121 reports

Product lines

• AzurionPhilips Medical Systems Nederland B.V. · 22 models · 9,199 reports · 71 recalls