Philips Allura Xper FD20 Biplane X-ray may not start reliably
Philips is recalling the Allura Xper FD20 Biplane 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 FD20 Biplane, system codes 722008 and 722013. About 461 units were distributed, 198 in the United States and 263 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 are listed by system code and serial number in the FDA enforcement record.
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 FD20 Biplane; System Code: (1) 722008, (2)722013;
- 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 (20)
- (1) System Code: 722008
- UDI: N/A
- System Serial Number: 360
- 361
- 445
- 296
- 487
- 390
- 306
- 178
- 420
- 267
- 245
- 2470
- 491
- 113
- 386
- 69
- 413
- 365
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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