Philips Azurion 5 M20 Patient Tables Recalled for Finger Entrapment Hazard
Philips Azurion 5 M20 x-ray system patient tables can trap fingers between the tabletop and guiding rails during repositioning. The hazard may cause finger injury to operators and service personnel.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with identified mechanical hazard capable of causing finger injury during normal operator use. No injuries have been reported in the source material, consistent with the rubric criterion for risk-of-harm products where injury has not yet been reported, warranting a High severity score.
Plain-English summary
The Philips Azurion 5 M20 x-ray imaging system patient tables (models AD7 and AD7X in both tilt and non-tilt versions) used in the Allura and Azurion systems are being recalled due to a finger entrapment hazard. During manual repositioning of the patient tabletop, fingers can become trapped between the longitudinal guiding rails and the tabletop surface.
The hazard affects operators and service personnel who manually reposition the patient table during clinical procedures and maintenance activities. A total of 68 units were distributed in the United States and 438 units outside the United States.
This is a Class II recall issued by the U.S. Food and Drug Administration. The recalling firm is Philips Medical Systems Nederland B.V.
The recalled product
- Product
- Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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 (3)
- UDI: (1) 722228 00884838099234(21)
- (2) 722232 00884838116757(21)
- (3) 722281 00884838110564(21)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 19 products in this recall →Related recalls
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