Recall Z-2891-2026 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura Xper FD10C; Model Number: 722001. 5. Allura Xper FD20; Model Numbers: 722006, 722012, 722028. 6. Allura Xper FD20 B
| Date | Aug 5, 2026 (initiated Jun 17, 2026) |
| Status | Open, Classified |
| Reason | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. |
| Root cause | Under Investigation by firm |
| Action | Philips notified consignees on about 06/17/2026 via letter sent certified mail titled, URGENT Medical Device Correction. Consignees were instructed to circulate the notification letter to all users of the system for awareness and to follow the instructions. In the case motorized movements are unavailable, the stand can be manually repositioned using the handgrips and brake controls located on both sides of the stand. For ceiling-mounted systems, manual longitudinal (1), transversal (2) and rotational (3) stand movements remain available. Note: Transversal stand movements (2) are only available |
| Quantity | 5,012 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102005 | ALLURA XPER OR TABLE SERIES Philips Medical Systems North America, Inc., Aug 9, 2010 |
| K130638 | ALLURACLARITY XPER FD SERIES X-RAY SYSTEM Philips Medical Systems Nederland B.V., Jun 28, 2013 |
| K130842 | ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES Philips Medical Systems Nederland B.V., May 21, 2013 |
| K133292 | ALLURA XPER FD; OR TABLE Philips Medical Systems Nederland B.V., Mar 5, 2014 |
| K141979 | ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES Philips Medical Systems Netherland BV, Aug 19, 2014 |