Medical device recalls Moderate risk

Philips North America, LLC recalls MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038

Recall date
December 30, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1489-2020
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

MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038

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