Recall Z-0981-2014 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
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 i
| Date | Feb 14, 2014 (initiated Nov 20, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | 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 foll |
| Quantity | 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, D |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081496 | OPTIMA PET/CT 560 Ge Medical Systems, LLC, Jun 12, 2008 |