Philips Allura CV20 X-ray System Recalled for Capacitor Failure
Philips is recalling 128 Allura CV20 X-ray systems because a capacitor may fail after electrical surges, 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 (no image acquisition) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips North America, LLC is recalling 128 units of the Allura CV20, system code 722031, X-ray system. The recall is due to a potential failure of a capacitor inside the converter of the Velara X-ray generator.
The capacitor may fail after a large number of surges in a short period of time. When this failure occurs, no image acquisition is possible. The source text does not report any injuries, illnesses, or deaths associated with this defect.
The affected units were distributed nationwide in the United States and worldwide. The source text notes that the units were not distributed in the US, which contradicts the distribution pattern field; however, the recall notice lists specific serial numbers for the affected units. Users should contact Philips for further instructions regarding the recall.
The recalled product
- Product
- Allura CV20, system code 722031
- Manufacturer
- Philips North America, LLC
- Affected units
- 128
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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