Philips Integris Allura 9 X-ray System Recall for Capacitor Failure
Philips is recalling 20 Integris Allura 9 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) with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips North America, LLC is recalling 20 units of the Integris Allura 9 X-ray system, specifically system codes 722018 and 722021. The recall is due to a potential failure of a capacitor inside the Velara X-ray generator. This failure can occur after a large number of surges in a short period of time.
When the capacitor fails, the system is unable to acquire images. The affected units were distributed domestically across the United States and internationally worldwide. The recall is classified as Class II by the FDA.
Healthcare facilities should contact Philips North America, LLC for instructions on how to address the defect. The source text does not report any injuries or illnesses associated with this recall.
The recalled product
- Product
- Integris Allura 9, system codes 722018 722021
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — X-ray System
- Hazard
- Affected units
- 20
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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