Medical device recalls Moderate risk

GE Healthcare, LLC recalls Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ…

Recall date
May 24, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0606-2019
FDA classification
Class II
Brand / firm
GE Healthcare, LLC
Sold / distributed
CA, DC, OH, UT, WI, Canada

Why it was recalled

When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard.

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

What was recalled

Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

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