The Recall Desk
ModerateFDA (Devices)·Z-1486-2020·Announced 2020-03-25

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.

What this means for you

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.
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.

See all 9 products in this recall →