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.

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.

GE Healthcare sent an Urgent Medical Device Correction letter dated November 20, 2013, and December 4, 2013, to all affected consignees. The letters described the Safety Issue, Safety Instructions, Affected Products Details, Product Correction and Contact Information ( In the US Call 1-800-437-1171. For other countries contact your local GE Healthcare Service Representative). Customers were given the following instructions: To avoid potential issues, replay the list mode data prior to another acquisition. In the event another acquisition is made before replaying the list data, or following reboot, do the following steps: Perform a PET only acquisition using the same tracer that is intended for the List Mode Replay. Then, proceed to perform the List Mode Replay and subsequent reconstructions. Make sure to perform a quality check on any images created after any replay of data. Affected Product Details PET Discovery 610 and PET Discovery 710, with software versions pet_coreload.44 and pet_mfk.44. The software version is visible on the homepage of the service desktop. To determine the software version currently on your system, do the following: 1. On the right monitor upper left corner select the Service Icon. 2. Verify that the Service window is under Home. 3. Locate the SW Build Version listed in the center of the page. For questions regarding this recall call 800-437-1171.