Philips AlluraXper FD20 Biplane Patient Table Finger Entrapment Risk
Philips AlluraXper FD20 Biplane patient tables may cause finger entrapment between the tabletop and guiding rails during manual repositioning, affecting operators and service personnel.
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: This is an FDA Class II medical device with a documented mechanical hazard (finger entrapment) that poses a risk of injury to operators and service personnel. No illnesses or injuries have been reported in the source text. Per the severity rubric, a risk-of-harm product where injury has not yet been reported scores as High (3).
Plain-English summary
The Philips AlluraXper FD20 Biplane System patient tables (both tilt and non-tilt versions) are subject to a recall due to a finger entrapment hazard. The affected devices have longitudinal guiding rails that can trap a finger between the rails and the patient tabletop during manual repositioning.
This hazard affects operators and service personnel who manually reposition the patient tabletop. Finger entrapment may result in finger injury. The affected systems have been distributed worldwide, including throughout the United States and Canada, and in numerous other countries.
Healthcare facilities using affected AlluraXper FD20 Biplane Systems should contact Philips Medical Systems Nederland B.V. for guidance on addressing this issue. The FDA has classified this as a Class II recall.
The recalled product
- Product
- AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- finger-entrapment
- crush-injury
Distribution
Distributed nationwide across the United States.
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