Philips Allura Xper FD10 OR Table X-ray may not start reliably
Philips is recalling the Allura Xper FD10 OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: imaging may not start when the operator expects it during a procedure, and no injuries are stated in the source.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling the Allura Xper FD10 OR Table, system codes 722022 and 722033. Two units were distributed, one in the United States and one outside it. The FDA has classified this recall as Class II.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Affected systems carry UDI 00884838059078 for system code 722022 (serial number 6) and UDI 00884838054233 for system code 722033 (serial number 1).
Facilities can identify affected systems by the system code and serial number above, and may contact Philips Medical Systems Nederland B.V. for further information.
The recalled product
- Product
- ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
- 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 (6)
- (1) System Code: 722022
- UDI: 00884838059078
- System Serial Number: 6
- (2) System Code: 722033
- UDI: 00884838054233
- System Serial Number: 1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 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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