Philips MultiDiagnost Eleva X-ray System Recalled for Capacitor Failure
Philips is recalling 534 MultiDiagnost Eleva 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, and the hazard is a functional failure (inability to acquire images) rather than a direct risk of physical injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Philips North America, LLC is recalling 534 units of the MultiDiagnost Eleva X-ray system, identified by specific system codes and serial numbers. The affected units were distributed domestically in the United States and internationally worldwide.
The recall is due to a potential failure of a capacitor inside the Velara X-ray generator converter. This failure can occur after the device experiences a large number of electrical surges in a short period of time. When the capacitor fails, the system is unable to acquire images.
Healthcare facilities and users should identify if they possess the affected units by checking the system codes and serial numbers listed in the official recall documentation. Users should contact Philips North America, LLC for further instructions on how to address the defect.
The recalled product
- Product
- MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 534
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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