Medical device recalls Moderate risk

GE Healthcare recalls PET Discovery LS

Recall date
July 17, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2802-2015
FDA classification
Class II
Brand / firm
GE Healthcare
Sold / distributed
Worldwide Distribution - US (nationwide) and to the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGRY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MEXICO, NORWAY, POLAND, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH A…

Why it was recalled

Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.

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

What was recalled

PET Discovery LS

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