Medical device recalls Moderate risk

GE Healthcare recalls GE Healthcare, Proteus XR/a with wall stand model number 600-0301.

Recall date
December 8, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0954-2015
FDA classification
Class II
Brand / firm
GE Healthcare
Sold / distributed
USA: All states in continental US including, Guam, DC. OUS; ARAB EMIRATES, AUSTRIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDONESIA, IRELAND, ISR…

Why it was recalled

GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported.

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

What was recalled

GE Healthcare, Proteus XR/a with wall stand model number 600-0301.

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