Philips Azurion 7M20 Fluoroscopic X-Ray System FlexArm Movement Recall
Philips Azurion 7M20 interventional fluoroscopic X-ray systems with FlexArm ceiling-mounted stands may experience inconsistent or unavailable longitudinal movement due to bearing grease leakage affecting device mobility. Approximately 927 systems worldwide are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device with no reported injuries, illnesses, or hospitalizations. The hazard is a mechanical/functional issue—bearing lubrication failure—that may reduce equipment mobility, characterized as a precautionary recall without documented patient impact.
Plain-English summary
Philips Azurion 7M20 systems with FlexArm ceiling-mounted stand are interventional fluoroscopic X-ray imaging systems. The affected systems have Model Numbers 722079 and 722224.
The motorized longitudinal movement mechanism of the FlexArm stand may become inconsistent or may eventually become unavailable. This issue occurs due to grease leakage from the bearings and/or anti-corrosion oil applied to the bearings. The leakage causes excessive lubrication on the ceiling rail, which reduces friction between the rails and the friction wheel, preventing smooth movement of the stand.
Approximately 927 systems have been distributed worldwide.
Healthcare facilities with affected systems should contact Philips Medical Systems Nederland B.V. for corrective action instructions. The movement dysfunction may impact clinical workflow and imaging procedures.
The recalled product
- Product
- Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Affected units
- 927
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: (01)00884838085268 (01)00884838099258
Distribution
Distributed nationwide across the United States.
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