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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Affected units
- 9,318
Distribution
Part of a larger recall action
This product is one of 4 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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