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.
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: 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.
- Affected units
- 648
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.
Part of a larger recall action
This product is one of 2 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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