Fluoroscopy System Component Deterioration May Disable Motorized Movements
Philips Allura CV20 fluoroscopy systems may lose motorized movement capability due to deterioration of internal components (battery, hard drive, power supply). Imaging and manual positioning remain available.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is functional degradation—loss of motorized movements—rather than a direct patient safety threat, as core imaging functionality and manual positioning remain available.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling 46 units of the Allura CV20 fluoroscopy system due to potential deterioration of internal components, including the CMOS battery, hard disk drive, and power supply unit.
When these components deteriorate, motorized movements of the imaging system will become unavailable. For ceiling-mounted systems, this includes longitudinal, transversal, and rotational movements. For floor-mounted systems, rotational movements will be unavailable. However, manual positioning of the stand and table longitudinal movements remain functional, and X-ray imaging capability is unaffected.
The affected units were distributed outside the United States. This is classified as an FDA Class II recall.
The recalled product
- Product
- Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- component-deterioration
- motorized-function-loss
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 Code: 722031
- UDI-DI: N/A
- Serial numbers: 155
- 150
- 87
- 88
- 109
- 97
- 138
- 86
- 152
- 135
- 153
- 35
- 76
- 133
- 173
- 124
- 92
- 166
Distribution
Distributed nationwide across the United States.
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