Philips Integris Allura 15-12 Fluoroscopy System Recalled for Standard Non-Compliance
Philips is recalling one Integris Allura 15-12 Fluoroscopy x-ray system in Florida because it failed to comply with a Federal standard.
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 hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems, Inc. is recalling one unit of the Integris Allura 15-12 Fluoroscopy x-ray system. The recall was initiated after field service testing revealed that the device failed to comply with a Federal standard.
The affected unit is identified by Model Number Integris Allura 15-12 and Serial Number 16741023. The device was distributed in the United States to Florida.
This is an FDA Class II recall. No specific injuries or illnesses have been reported in the source text. Healthcare facilities should contact Philips for instructions on how to address the non-compliance.
The recalled product
- Product
- Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
- Manufacturer
- Philips Medical Systems, Inc.
- Hazard
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)
- Model Number: Integris Allura 15-12 Serial Number: 16741023
Distribution
Distributed in 1 state:
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