Medical device recalls Moderate risk

GE OEC Medical Systems, Inc recalls OEC 9800, fluoroscopic x-ray system

Recall date
July 22, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2629-2016
FDA classification
Class II
Brand / firm
GE OEC Medical Systems, Inc
Sold / distributed
Distribution US nationwide and Korea.

Why it was recalled

A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.

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

What was recalled

OEC 9800, fluoroscopic x-ray system

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