Philips Allura Xper Fluoroscopy Systems Cable Hose Carrier Detachment
Philips Allura Xper FD series fluoroscopy systems may have detached cable hose carriers due to broken plastic or bolts. A detachment could cause parts to fall and potentially result in injury.
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: FDA Class II recall with potential for injury from cable hose carrier detachment. No injuries or hospitalizations have been reported. The hazard is mechanical failure with theoretical injury risk, meeting the criteria for Score 3 (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling certain models of its Allura Xper FD series fluoroscopy systems. These are medical imaging devices used in hospitals and clinical facilities for angiography and fluoroscopic procedures.
The cable hose carrier on these systems may detach due to broken plastic components or loose or broken bolts. If the carrier detaches, cable hoses may drop or parts may fall, creating a potential injury hazard.
Approximately 9,318 units have been distributed in the United States, Canada, and worldwide.
The recalled product
- Product
- System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 Allura Xper FD20 OR Table 722029 Allura Xper FD20/10 722028 Allura Xper FD20 722027 Allura Xper FD10/10 722026 Allura Xper FD10 722025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- cable-detachment
- falling-parts
- mechanical-failure
Distribution
Distributed nationwide across the United States.
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