FDA-Device2026-05-27Class IIPROCESSING DEFECT
Philips Azurion X-ray systems recalled for impaired table movement due to control wear
OTHERNationwide distribution
Philips Azurion X-ray systems recalled for table movement risk
Certain Philips Azurion fluoroscopy systems may experience mechanical wear in the Float Tabletop control, which could impair the longitudinal and transverse (side-to-side and front-to-back) movement of the examination table. This wear could affect the system's ability to position patients correctly during imaging procedures.
- If you operate or maintain one of the affected Azurion models, contact Philips Medical Systems Nederland B.V. for service guidance.
- Do not continue using the system if table movement becomes difficult or unresponsive.
- Check the FDA or manufacturer website for available corrective actions or software updates.
Hazard
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
Sold states
Nationwide distribution. International distribution to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, C¿te D'Ivoire, El Salvador, Estonia, Greece, Honduras, Hong Kong, Iceland, Indonesia, Iraq, Japan, Kyrgyzstan, Malaysia, Malta, Moldova, Nepal, New Zealand, Philippines, Qatar, Singapore, South Africa, Sri Lanka, Syrian Arab Republic, Tanzania, Turkmenistan, Vietnam, Yemen
Affected count
5,537 units
Manufactured in
Veenpluis 6, Best, Netherlands
Products
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2225-2026More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for cooling hose degradation risk
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- FDA-Device2026-05-20Philips Azurion imaging systems recalled for cable hose carrier failure risk
- FDA-Device2026-04-22Philips AneurysmFlow software recalled for unreliable aneurysm flow measurement
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