Philips OmniDiagnost Eleva System Recalled Due to Capacitor Failure
Philips is recalling 69 OmniDiagnost Eleva 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 source text describes a functional failure (no image acquisition) rather than a safety hazard involving injury or death, aligning with the 'Moderate' criteria for low-risk issues.
Plain-English summary
Philips North America, LLC is recalling 69 units of the OmniDiagnost Eleva System (codes 708028 and 708027). 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 experiencing a large number of surges in a short period of time. When this failure occurs, the system is unable to acquire images. The affected units were distributed domestically nationwide and internationally worldwide.
No specific instructions for consumers are provided in the source text, but the recall indicates a functional defect that prevents the device from operating as intended.
The recalled product
- Product
- OmniDiagnost Eleva System codes 708028 708027
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — X-ray Generator
- Hazard
- Affected units
- 69
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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