Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with correspon
FDA device recall Z-2503-2025 · posted 2025-09-03 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Reason for recall
- Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
- Action taken
- Philips notified consignees on about 08/01/2025 via letter. Consignees were informed that systems may still be utilized in accordance with their Instructions for Use (IFU), notify all applicable personnel of this recall, maintain the Urgent Medical Device Correction letter with documentation of the system until Philips corrects the system, and establish an emergency protocol prior to all applicable diagnostics, interventional and minimally invasive procedures to manage the situation should you experience the issue during a procedure. If an affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. Additionally, consignees were requested to complete and return the provided response form and report any issue experienced to Philips.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 1,006 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus,
- Date initiated
- 2025-08-01
- Date posted
- 2025-09-03
- Location
- Best, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Allura Xper R9 (K163715) | Philips Medical Systems Nederland B.V. | 2017-01-26 |
| Allura Xper FD series and Allura Xper OR Table series (K162859) | Philips Medical Systems Nederland B.V. | 2016-12-02 |
| ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES (K141979) | Philips Medical Systems Netherland BV | 2014-08-19 |
| ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES (K130842) | Philips Medical Systems Nederland B.V. | 2013-05-21 |
| ALLURA XPER OR TABLE SERIES (K102005) | Philips Medical Systems North America, Inc. | 2010-08-09 |