Philips Azurion and Allura Patient Table Finger Entrapment Risk
Philips Azurion 7 M20 and Allura patient tables pose a finger entrapment risk during manual repositioning. Fingers can get caught between the tabletop and guiding rails, 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: This is a Class II medical device recall with a risk-of-harm hazard where no injuries have been reported. The source states the injury 'may result,' indicating potential but not realized harm. Per the rubric, this qualifies as 'High' severity for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Philips Azurion 7 M20 and Allura systems contain patient examination tables (both tilt and non-tilt versions) with a design that poses a finger entrapment risk during operation.
During manual repositioning of the patient tabletop, fingers can become entrapped between the tabletop and the longitudinal guiding rails. This may result in finger injury to the affected person.
Operators and service personnel who manually reposition the patient table are at risk of finger entrapment and injury. The recall affects 1,346 units in the United States and 2,582 units worldwide distributed across multiple countries.
Facilities using these systems should review safe handling procedures with all personnel who operate or service the equipment. For specific remediation steps, replacement options, or additional information, contact Philips Medical Systems Nederland B.V. or the FDA.
The recalled product
- Product
- Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
- 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 (4)
- UDI: (1) 722224 00884838099258(21)
- (2) 722079 00884838085268(21)
- (3) 722234 00884838116771(21)
- (4) 722282 00884838110571(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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