X-ray Fluoroscopy System Motorized Movement Failure from Internal Component Deterioration
Allura Xper FD20 X-ray fluoroscopy systems may experience internal component deterioration, causing loss of motorized movements. Manual positioning and imaging functionality remain available.
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: Class II recall with no reported deaths, hospitalizations, or injuries. The recall addresses potential loss of motorized positioning on a medical imaging device while core imaging functionality and manual controls remain available. This represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling 2,114 Allura Xper FD20 X-ray fluoroscopy systems due to potential deterioration of internal components including the CMOS battery, hard disk drive, and power supply unit. This deterioration can cause the motorized movement functions of the system to become unavailable.
If motorized movement becomes unavailable, users will lose the ability to automatically adjust the system's stand and table positions. However, manual positioning remains available for stand movements (longitudinal, transversal, and rotational for ceiling-mounted systems; rotational only for floor-mounted systems) and table longitudinal movements. X-ray imaging functionality is unaffected.
The recall affects 791 units in the United States and 1,323 units internationally across numerous countries. Healthcare providers should contact Philips Medical Systems Nederland B.V. for information about inspecting, repairing, or replacing the affected components.
The recalled product
- Product
- Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- component-deterioration
- motorized-movement-failure
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)
- Product Codes: (1)722012
- (2) 722028
- (3) 722006
- UDI-DI: (1) 00884838059054
- (2) 00884838054202
- (3) N/A
- Serial numbers: (1) 919
- 1581
- 1117
- 1001
- 1673
- 1712
- 585
- 517
- 1545
- 1715
- 504
- 757
- 935
- 1356
Distribution
Distributed nationwide across the United States.
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