Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Device class: 2
Device name: Interventional Fluoroscopic X-Ray System
Event initiated: 2026-06-17
FDA posted: 2026-08-05
Recall ID: Z-2891-2026
Product: 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 Biplane; Model Numbers: 722008, 722013.
7. Allura Xper FD20 Biplane OR Table; Model Number: 722025.
8. Allura Xper FD20 OR Table; Model Numbers: 722015, 722023, 722035.
9. Allura Xper FD20/10; Model Number: 722029.
10. Allura Xper FD20/15; Model Number: 722058.
11. Allura Xper FD20/15 OR Table; Model Number: 722059.
12. Allura Xper FD20/20; Model Number: 722038.
13. Allura Xper FD20/20 OR Table; Model Number: 722039.
14. Allura Xper R9 7 M12; Model Number: 722065.
15. Allura Xper R9 7 M20; Model Number: 722066.
Interventional Fluoroscopic X-Ray System.
Reason for recall
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.