Philips Allura Xper FD10C X-ray may not start from foot switch
Philips is recalling the Allura Xper FD10C 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 FD10C, system code 722001. About 15 units were distributed, 7 in the United States and 8 outside it, across more than a hundred countries. 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 system code 722001, across fifteen listed system serial numbers.
Facilities can identify affected systems by the system code and serial number, and may contact Philips Medical Systems Nederland B.V. for further information.
The recalled product
- Product
- Allura Xper FD10C; System Code: 722001;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- imaging-failure
- foot-switch-fault
- procedure-risk
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 (17)
- System Code: 722001
- UDI: N/A
- System Serial Number: 19
- 249
- 21
- 18661014
- 77
- 82
- 195
- 216
- 337
- 37
- 258
- 283
- 15
- 256
- 305
Distribution
Distributed nationwide across the United States.
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