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GE Healthcare, LLC recalls GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained
Recalled October 31, 2012 · FDA recall Z-0121-2013 · GE Healthcare
Hazard
GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery NM630 system which may impact operation safety. At scan setup, during gantry rotation towards scanning position, a potential contact between the table-pallet-edge and the detector was identified. Such occurrence may damage the pallet front-edge and · FDA Class II
Units
210
Sold at
Worldwide distribution: USA (Nationwide) in the states of: AL, CA, FL, GA, IL, IN, KS, LA, MD, MA, MN, MS, MO, NJ, NY, NC, OH, OK, PA, SC, TN, TX, VA, WI and WV. AUSTRALIA, BELGIUM, CANADA, CHINA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GUADELOUPE, HONG KONG, INDIA, IRELAND, ISRAEL,ITALY, JAPAN, REPUBLIC OF KOREA, NETHERLANDS,NORWAY, POLAND, RUSSIAN FEDERATION, SPAIN, SWITZERLAND, TAIWAN,THAILAND, TURKEY, UNITED KINGDOM.
Description
GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery NM630 system which may impact operation safety. At scan setup, during gantry rotation towards scanning position, a potential contact between the table-pallet-edge and the detector was identified. Such occurrence may damage the pallet front-edge and
Product
GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid 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. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →