Fluoroscopic X-ray systems recalled over air baffle missing from internal PCs
Philips Allura Xper interventional fluoroscopic X-ray systems are recalled because an air baffle component may be missing in some Nehalem FlexVision-2 PCs. 192 units are affected.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice reports a possibly missing internal component without stating any patient consequence.
Plain-English summary
Philips Allura Xper series interventional fluoroscopic X-ray systems are being recalled, covering the Allura Xper FD10 (model 722003), Allura Xper FD10/10 (model 722005) and Allura Xper FD20, with serial numbers listed in the recall notice. The recall covers 192 units distributed nationwide in the United States and internationally.
The recall was issued because of the potential that a component, an air baffle, may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series. The FDA classified the action as Class II. The notice does not describe a further consequence.
Imaging sites operating these systems should follow the manufacturer's instructions for inspection and correction.
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.…
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — Imaging System
- Affected units
- 192
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
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