Philips AlluraXper FD20 operating room surgical table finger entrapment risk
Philips AlluraXper FD20 operating room tables can trap fingers during manual repositioning, risking injury. The hazard affects both operators and service personnel worldwide.
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 recall involves a risk-of-harm product (surgical equipment) with a credible finger entrapment hazard, but no injuries are reported in the source material. The FDA's Class II classification and potential for injury to operators and service personnel support a High severity rating per the rubric.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the AlluraXper FD20 Biplane OR Table, a surgical operating room table used in hospitals and medical facilities worldwide. The recall addresses a finger entrapment hazard.
During manual repositioning of the patient tabletop, a finger can become entrapped between the longitudinal guiding rails and the tabletop. This entrapment may result in finger injury affecting both operators who reposition the table and service personnel who perform maintenance and adjustments.
The affected systems, with codes 722020 and 722025, have been distributed worldwide, including throughout the United States and numerous other countries. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Affected units
- 1
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.
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