Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Im
FDA device recall Z-2534-2024 · posted 2024-08-08 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Reason for recall
- Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
- Action taken
- Philips issued URGENT Medical Device Correction Letter to US consignees on July 15th, 2024, via certified mail. Letter states reason for recall, health risk and action to take: Circulate this Urgent Medical Device Correction to all users of the system so that they are aware of the issue. " Keep this Urgent Medical Device Correction with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. " Should you experience a loss of imaging (X-ray) functionality or a prolonged system restart time, call your local Philips representative to report the event. " Complete and return the attached response form (page 4) to Philips promptly and no later than 30 days from receipt. This confirms that the users of the system have reviewed and understand this Urgent Medical Device Correction and required actions to be taken. Philips is working on a software release (R2.2.10) that will correct these two issues (ref. FCOs: FCO72200548, FCO72200580, FCO72200582, FCO72200583, FCO72200584, FCO72200592). For those systems that have an Interventional Workspot (IW) and/or EchoNavigator, Philips will upgrade the software version of the IW and/or EchoNavigator to maintain compatibility with the updated Philips Azurion system software (R2.2.10). Your local Philips representative will contact you to schedule a visit to install the software update once available. Philips expects this software to be released by Q1 2025. If you need additional information or support concerning these issues, contact your local Philips representative at 1-800- 722-9377 (Philips Customer Care Solutions Center).
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 3011 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzego
- Date initiated
- 2024-07-15
- Date posted
- 2024-08-08
- Location
- Best, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Azurion R2.1 (K200917) | Philips Medical Systems Nederland B.V. | 2020-05-01 |