Recall archive / FDA device enforcement
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Nu... — FDA record Z-2891-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 17, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 5,012 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2891-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, 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(01)00884838059030(21)948, (01)00884838059030(21)664, (01)00884838059030(21)663, (01)00884838059030(21)304, (01)00884838059030(21)1021, (01)00884838059030(21)1422, (01)0088... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 12, 2026
- Recall initiation date
- Jun 17, 2026
- Center classification date
- Aug 5, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.