DeviceSignal · Recall classified
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA classified a device recall on 2026-08-05 · Class II · Z-2892-2026
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 Azurion under the following System Descriptions and corresponding model numbers…. Recall Z-2892-2026. The firm initiated it on 2026-06-17. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2892-2026
- 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 Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 722228, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225. 6. Azurion 7 B20; Model Numbers: 722068, 722226. 7. Azurion 7 M12; Model Numbers: 722078, 722223. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722282. 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-2892-2026- 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
360338568b8b6856ec8404d5a2d91e0eca6532de186e88f498ab016ed15f47aa- 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)