Philips Azurion and Allura Patient Tables: Finger Entrapment Hazard
Philips patient tables on Azurion and Allura imaging systems can trap fingers between the tabletop and rails during manual repositioning. Operators and service personnel are at risk of finger injury.
What this means for you
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 recall involving a risk-of-harm hazard (finger entrapment). No reported injuries have been documented, fitting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems is recalling certain patient tables (AD7 and AD7X models, both tilt and non-tilt versions) used with Azurion and Allura imaging systems. During manual repositioning of the tabletop, a finger can become entrapped between the longitudinal guiding rails and the patient table surface.
This hazard affects operators and service personnel who manually reposition the patient tables during use or service. Finger entrapment can result in injury.
The affected units have been distributed worldwide, including 9 units in the United States and 101 units outside the United States. If you operate or service these systems, contact Philips Medical Systems Nederland B.V. for information about mitigation options.
The recalled product
- Product
- Azurion 3 M12 System Code: (1) 722063 (2) 722221
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- finger-entrapment
- crush-injury
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: (1) 722063 00884838085275(21) (2) 722221 00884838099203(21)
Distribution
Distributed nationwide across the United States.
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