Philips Integris Allura X-ray Systems Recalled for Capacitor Failure
Philips is recalling 70 Integris Allura 15 & 12 X-ray systems because a capacitor may fail, preventing image acquisition.
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, but the hazard is a functional failure (loss of image acquisition) rather than a direct physical injury or death risk, fitting the criteria for moderate severity.
Plain-English summary
Philips North America, LLC is recalling 70 units of the Integris Allura 15 & 12 X-ray systems, including both monoplane (system code 722043) and biplane (system code 722044) configurations. The recall involves specific serial codes listed in the agency documentation.
The recall is due to a potential failure of a capacitor inside the converter of the Velara X-ray generator. This failure may occur after a large number of surges in a short period of time. When the capacitor fails, no image acquisition is possible.
The affected units were distributed nationwide in the United States and worldwide. Users should contact Philips North America, LLC for further instructions on how to address the issue.
The recalled product
- Product
- Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — X-ray Systems
- Hazard
- Affected units
- 70
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Philips North America, LLC 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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