Philips Recalls Azurion X-ray Systems Due to Software Defect
Philips is recalling 229 Azurion Interventional Fluoroscopic X-ray Systems because a software defect may cause radiation levels too low for diagnostic images.
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: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Medical Systems Nederlands is recalling 229 units of the Azurion Interventional Fluoroscopic X-ray System, specifically those equipped with software version 1.2. The recall was initiated after the manufacturer identified an intermittent electronic product defect through customer complaints and internal testing.
The defect affects the automatic exposure control software. When performing Cine runs, the software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images. This issue is classified as an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1).
The affected devices were distributed nationwide. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
- Manufacturer
- Philips Medical Systems Nederlands
- Affected units
- 229
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 (1)
- software version R1.2
Distribution
Distributed nationwide across the United States.
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