Philips Velara X-ray Generator Recalled for Capacitor Failure
Philips is recalling the Velara X-ray generator 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. The hazard is a functional failure (inability to acquire images) rather than a direct physical injury or death, fitting the criteria for moderate severity.
Plain-English summary
Philips North America, LLC is recalling the Poly G Integris H5000 (System code 72246) X-ray generator. The recall is due to a potential failure of a capacitor inside the converter. 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 equipment has the system equipment number 519212. One unit is involved in this recall.
The product was distributed nationwide in the United States and worldwide. Users should contact Philips North America, LLC for further instructions regarding the recall.
The recalled product
- Product
- Poly G Integris H5000, System code 72246
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — X-ray Generator
- Hazard
- Affected units
- 1
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)
- System equipment number 519212
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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