Medical device recalls Moderate risk

GE Healthcare, LLC recalls Proteus XR/a (SlOK : K993090)

Recall date
August 9, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2449-2019
FDA classification
Class II
Brand / firm
GE Healthcare, LLC
Sold / distributed
Worldwide - US Nationwide

Why it was recalled

Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

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

What was recalled

Proteus XR/a (SlOK : K993090)

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