Medical device recalls Moderate risk

GE Healthcare, LLC recalls Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

Recall date
December 3, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1710-2020
FDA classification
Class II
Brand / firm
GE Healthcare, LLC
Sold / distributed
US Nationwide Distribution

Why it was recalled

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

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

What was recalled

Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

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