Medical device recalls Moderate risk

Philips North America, LLC recalls Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 72201…

Recall date
December 30, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1486-2020
FDA classification
Class II
Brand / firm
Philips North America, LLC
Sold / distributed
Nationwide domestic distribution. Foreign distribution worldwide.

Why it was recalled

A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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