PlainRecalls
FDA Devices Moderate Class II Terminated

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 (molec

Reported: February 26, 2014 Initiated: November 20, 2013 #Z-0981-2014

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
376 (101 US, 275 OUS)
Distribution
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.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by GE Healthcare, LLC. Units affected: 376 (101 US, 275 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2014. Severity: Moderate. Recall number: Z-0981-2014.

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