X-ray Imaging System Carriage Bolts May Loosen or Break
Philips Allura Xper FD10 and FD20 X-ray systems may have loose or broken bolts supporting the FlexMove Carriage and cracks in the suspension rail. Affected units distributed worldwide; users should inspect equipment and contact manufacturer.
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: This is an FDA Class II recall of a medical device with a structural defect (loose or broken bolts, cracked suspension rail) that could cause equipment malfunction. The source text does not report any illnesses or injuries, making this a risk-of-harm product where injury has not yet been reported, justifying a High severity per the rubric.
Plain-English summary
Philips Medical Systems Nederland B.V. has recalled 648 Allura Xper FD10 and FD20 X-ray Imaging Systems due to a structural defect in the FlexMove Carriage assembly. The bolts supporting the carriage may become loose or break, and cracks may appear in the suspension rail.
These systems were distributed worldwide to the United States and more than 40 countries, including Australia, Brazil, China, France, Germany, Japan, South Korea, and the United Kingdom.
A loose, broken, or cracked suspension component could cause unexpected movement or malfunction of the X-ray imaging equipment during clinical use. No injuries or illnesses have been reported as of the recall notice date.
Hospitals and medical facilities using affected systems should immediately inspect their equipment and contact Philips Medical Systems for repair and replacement guidance. This is an FDA Class II recall, indicating potential device malfunction.
The recalled product
- Product
- Allura Xper FD10 and FD20. X-ray Imaging System.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- loose-bolts
- broken-bolts
- rail-cracks
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)
- Model No.: 722010
- 722012
- 722022
- 722023
- 722026
- 722028
- 722033
- 722035
- UDI-DI: (01)00884838054189(21)
- (01)00884838054202(21)
- (01)00884838054240(21)
- (01)00884838059054(21)
- (01)00884838059085(21)
- (01)00884838059191(10)
- (01)00884838059283(10)
- System Equipment Number: 52756450
- 53152280
- 53339159
- 53341109
- 53362649
Distribution
Distributed nationwide across the United States.
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