Recall Z-1551-2013 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 PET VCAR (Volume Computer Assisted Reading) is a PET/CT sof
| Date | Jun 18, 2013 (initiated May 9, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR application on Advantage Workstation or AW Server. |
| Root cause | Software design |
| Action | GE Healthcare sent an "Urgent Medical Device Correction" letter dated May 14, 2013, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to call one of the following numbers: United Sates 800-437-1171 Japan 0120-055-919 For other countries they were instructed to contact their local GE Healthcare Service Representative. For questions regarding this recall call 407-475-4717. |
| Quantity | 231 (38 US; 193 OUS) |
| Distribution | Worldwide Distribution - USA including CA, CO, CT, FL, GA, IL, NY, NY NC OH, TX, VA, WV, WI. Internationally to: AUSTRALIA, AUSTRIA, BAHARIN, CANADA, CHILE, CHINE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GEORGIA, GERMANY, HONG KONG, INDIA, INDONESIA, ITALY, JAPAN, KOREA, MEXICO, MOROCCO, NIGERIA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063324 | PET VCAR GE Healthcare, Mar 23, 2007 |