Finger entrapment hazard in Philips Allura fluoroscopy patient tables
Philips is recalling AD7 and AD7X patient tables from Allura and Azurion fluoroscopy systems. During manual repositioning, fingers can become trapped between the guiding rails and tabletop, potentially causing 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: This is an FDA Class II recall. No illnesses or injuries have been reported. The hazard represents a risk-of-harm where potential injury has not yet been documented, meeting the rubric criterion for Score 3 (High).
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the AD7 and AD7X patient tables (both tilt and non-tilt versions) that are part of Allura and Azurion fluoroscopy systems. These tables are used for patient positioning during diagnostic imaging procedures.
During manual repositioning of the patient tabletop, a finger can become entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury to the finger. The hazard affects both operators and service personnel who manually reposition the tables.
The recall impacts 33 units in the United States and 82 units distributed internationally. Healthcare facilities should contact Philips Medical Systems Nederland B.V. for additional information regarding this recall.
The recalled product
- Product
- Allura Xper FD20/20 System Code: (1) 722038
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — Patient Table
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: 00884838054226(21)
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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