DeviceSignal · Recall classified
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA classified a device recall on 2026-08-05 · Class II · Z-2891-2026
EventRecall classified
Effective2026-08-05
ClassificationClass II
On 2026-08-05 the FDA classified a device recall from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. as Class II. Product: Philips Allura under the following System Descriptions and corresponding model numbers…. Recall Z-2891-2026. The firm initiated it on 2026-06-17. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2891-2026
- Classification
- Class II
- Classified on
- 2026-08-05
- Initiated on
- 2026-06-17
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- 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; 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.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2891-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
c3b7c990d2982ce68683b9a24b9e591716a2f6ecfa8d5b5c60af829e863f1b7f- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)