DeviceSignal · Recall classified
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA classified a device recall on 2026-08-10 · Class II · Z-2931-2026
EventRecall classified
Effective2026-08-10
ClassificationClass II
On 2026-08-10 the FDA classified a device recall from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. as Class II. Product: Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079…. Recall Z-2931-2026. The firm initiated it on 2026-07-16. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2931-2026
- Classification
- Class II
- Classified on
- 2026-08-10
- Initiated on
- 2026-07-16
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Reason
- Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
- Product
- Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); 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-2931-2026- 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
612fa298f2ffc6a411c5e7531ccfbe92956a6038cf7ef2eac3d981435429545d- 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)