Philips Azurion Patient Tables Recalled for Finger Entrapment Risk
Philips Azurion patient tables used in medical imaging systems can trap fingers between the tabletop and rails during manual repositioning, potentially causing 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: The recall is FDA Class II without reported hospitalizations or injuries. However, the hazard presents a real risk of harm—mechanical finger entrapment—even though no injuries have been reported. This aligns with the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The recall involves patient tables (AD7 and AD7X models, both tilt and non-tilt versions) used in the Philips Azurion 3 M15 imaging system. During manual repositioning of the patient tabletop, a finger can become entrapped between the longitudinal guiding rails and the tabletop.
This mechanical hazard may result in finger injury. The hazard affects operators and service personnel who manually reposition the patient tables.
Approximately 42 units are distributed in the United States and 661 units are distributed internationally across numerous countries. Healthcare facilities with affected systems should contact Philips Medical Systems Nederland B.V. for further information and corrective measures.
The recalled product
- Product
- Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280
- 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) 722064 00884838085282(21)
- (2) 722222 00884838099210(21)
- (3) 722280 00884838103276(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.
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