Philips AlluraXper Patient Tables Pose Finger Entrapment Risk
Philips is recalling AD7 and AD7X patient tables used in Allura and Azurion fluoroscopy systems. Manual repositioning can trap fingers between the tabletop and rails, risking injury to 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: FDA Class II device with an identified pinch-and-entrapment hazard, but no reported injuries or illnesses as stated in the source. Meets the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems is recalling the AD7 and AD7X patient tables (both tilt and non-tilt versions) that are components of the Philips Allura and Azurion fluoroscopy systems. The affected devices are identified by system codes 722005, 722011, and 722027. A total of 146 units are in use in the United States and 629 units are in international markets.
During manual repositioning of the patient tabletop, a finger can become trapped between the longitudinal guiding rails and the tabletop. This creates a risk of finger injury to operators and service personnel.
Healthcare facilities and service providers using these systems should be alert to this finger entrapment hazard. When performing manual repositioning of the patient table, exercise appropriate caution to prevent injury.
The recalled product
- Product
- AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- finger-entrapment
- pinch-injury
Distribution
Distributed nationwide across the United States.
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