GE Healthcare, LLC recalls GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems

Recalled February 26, 2014 · FDA recall Z-0981-2014 · GE Healthcare

Hazard

GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600, 610, 710 and Discovery 690. · FDA Class II

Units

376 (101 US, 275 OUS)

Sold at

Worldwide Distribution - USA including AL, AZ, AR, CA, CO, FL, GA, IL, IN, IA, KY, LA, MN, MO, NE, NJ, NM, NY, NC, OH, OK, PA, SD, TN, TX, UT, VA, WA, WV, WI and Internationally to: AUSTRALIA, AUSTRIA BELGIUM BOSNIA AND HERZEGOVINA, BRAZIL, CANADA, CHILE, COLOMBIA, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, FINLAND, GEORGIA, GERMANY, HONG KONG, IRAN, ISRAEL INDIA,M ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NEW ZEALAND, NORWAY, RUSSIA, REPUBLIC OF KOREA, POLAND, ROMANIA, SAUDI ARABIA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TUNISIA, THAILAND, TURKEY, UNITED KINGDOM.

Description

GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600, 610, 710 and Discovery 690.

Product

GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.

Manufacturer(s)

GE Healthcare, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →