Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/1
FDA device recall Z-2189-2025 · posted 2025-07-29 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Reason for recall
- Potential for temporary loss of imaging (X-ray) functionality due to software issue.
- Action taken
- Philips notified consignees on 06/30/2025 via letter. Consignees were informed what the issue was and under what circumstances it can occur and how to identify affected units. Consignees were instructed to notify all relevant personnel, avoid rapidly pressing and releasing the footswitch pedals, if the X-ray functionality is not available during the issues described in the notification, follow specific outlined steps, and notify customers if the units have been transferred or further distributed. Additionally, consignees were requested to maintain the notification with the system until the software update is complete and to complete and return the response form.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 4,508 units
- Distribution
- Worldwide - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa
- Date initiated
- 2025-06-30
- Date posted
- 2025-07-29
- Location
- Best, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Allura Xper FD series and Allura Xper OR Table series (K162859) | Philips Medical Systems Nederland B.V. | 2016-12-02 |
| Allura Xper FD series and Allura Xper OR Table series (K161563) | Philips Medical Systems Nederland B.V. | 2016-07-29 |
| ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES (K141979) | Philips Medical Systems Netherland BV | 2014-08-19 |
| ALLURA XPER FD; OR TABLE (K133292) | Philips Medical Systems Nederland B.V. | 2014-03-05 |