Philips Allura Exper FD Series X-Ray Generator Recall
Philips is recalling Allura Exper FD Series X-ray generators 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 safety risk like radiation exposure or electrical shock, and no injuries or illnesses are reported.
Plain-English summary
Philips North America, LLC is recalling the Allura Exper FD Series X-ray generator. The recall involves 4,938 units distributed nationwide and worldwide.
The recall is due to a potential failure of a capacitor inside the converter of the Velara X-ray generator. This failure may occur after a large number of surges in a short period of time. When this failure occurs, no image acquisition is possible.
Affected units are identified by specific system codes and serial codes listed in the official recall notice. Users should contact Philips North America, LLC for further instructions on the recall.
The recalled product
- Product
- Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 4,938
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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