Medical device recalls Moderate risk

GE Healthcare, LLC recalls Optima CT 520

Recall date
May 24, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2585-2018
FDA classification
Class II
Brand / firm
GE Healthcare, LLC
Sold / distributed
Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.

Why it was recalled

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

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

What was recalled

Optima CT 520

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