FDA Device recall Z-2891-2026
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10
- FDA Device
- Class II
- ongoing
- Published 2026-08-12
On 2026-08-12 the FDA classified a Class II recall of Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10 by Philips Medical Systems Nederland B V, citing potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2891-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-17 |
| Published | 2026-08-12 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
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
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Identifiers
| code_info | 1. Allura Xper FD10; Model Numbers (UDI Numbers): 722003 (N/A), 722010 ((01)00884838059030(21)754, (01)00884838059030(2…1. Allura Xper FD10; Model Numbers (UDI Numbers): 722003 (N/A), 722010 ((01)00884838059030(21)754, (01)00884838059030(21)42, (01)00884838059030(21)500, (01)00884838059030(21)68, (01)00884838059030(21)521, (01)00884838059030(21)33, (01)00884838059030(21)1025, (01)00884838059030(21)668, (01)00884838059030(21)585, (01)00884838059030(21)641, (01)00884838059030(21)968, (01)00884838059030(21)890, (01)00884838059030(21)780, (01)00884838059030(21)667, (01)00884838059030(21)1279, (01)00884838059030(21)344, (01)00884838059030(21)359, (01)00884838059030(21)423, (01)00884838059030(21)1040, (01)00884838059030(21)478, (01)00884838059030(21)215, (01)00884838059030(21)1298, (01)00884838059030(21)970, (01)00884838059030(21)1226, (01)00884838059030(21)365, (01)00884838059030(21)1328, (01)00884838059030(21)1292, (01)00884838059030(21)1275, (01)00884838059030(21)755, (01)00884838059030(21)671, (01)00884838059030(21)677, (01)00884838059030(21)61, (01)00884838059030(21)477, (01)00884838059030(21)1078, (01)0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2891-2026%22
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