Philips Allura Xper X-Ray Systems Recalled for Potentially Missing Component
Philips is recalling 192 Allura Xper Series interventional fluoroscopic X-ray systems because an air baffle component may be missing from some units. The systems have been distributed in multiple U.S. states and internationally.
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 FDA Class II medical device recall involves a potentially missing component that could affect proper device function. No illnesses or injuries have been reported. Per FDA guidelines, risk-of-harm products without reported injuries are classified as High severity.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling 192 Allura Xper Series interventional fluoroscopic X-ray systems due to a potentially missing component. The recall affects 16 model variants of the Allura Xper system.
A component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series. These systems have been distributed in multiple U.S. states and internationally across North America, Europe, Asia, and South America.
Healthcare facilities that may have received these systems should verify whether their equipment is affected by contacting Philips Medical Systems Nederland B.V. or checking the FDA recall notice. Information on affected models and serial numbers is available from the FDA.
The recalled product
- Product
- Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. All
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- missing-component
- device-defect
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)
- 1. Model Number/System Code (UDI)
- Serial Numbers: 722003 (No UDI)
- 292
- 314
- 1077
- 464. 2. Model Number/System Code (UDI)
- Serial Numbers: 722005 (No UDI)
- 54. 3. Model Number/System Code (UDI)
- Serial Numbers: 722006 (No UDI)
- 2126
- 2200
- 1560
- 1921
- 1724
- 1219. 4. Model Number/System Code (UDI)
- Serial Numbers: 722008 (No UDI)
- 516
- 142
- 434
- 418
Distribution
Distributed nationwide across the United States.
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