Class II — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. |
| 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; Mo… |
| Quantity | 5,012 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2026-06-17 |
| Classified | 2026-08-05 |
| Recall number | Z-2891-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. (Z-2891-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99313/
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