Philips AlluraXper Operating Room Table Finger Entrapment Hazard
The Philips AlluraXper FD20 operating room table can trap fingers between the guiding rails and tabletop during manual repositioning, potentially injuring 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 FDA recall involving a clear mechanism of injury (finger entrapment) that could cause significant trauma to fingers and hands of operators and service personnel. No injuries have been reported; the hazard is theoretical risk-of-harm, which per the severity rubric warrants a score of 3 (High).
Plain-English summary
The Philips AlluraXper FD20 OR Table (part of Philips Allura and Azurion systems) is being recalled due to a finger entrapment hazard. During manual repositioning of the patient tabletop, a finger can become trapped between the longitudinal guiding rails and the tabletop itself.
This entrapment can result in finger injury to operators and service personnel who manually reposition the patient table. The hazard affects both tilt and non-tilt versions of the patient tables.
Healthcare facilities using these systems should be aware of this entrapment hazard during manual tabletop repositioning and contact the manufacturer or FDA for guidance on mitigation strategies or product updates.
The recalled product
- Product
- AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
- 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 (1)
- UDI: N/A
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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