Recall Z-1148-2014 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system
| Date | Mar 6, 2014 (initiated Mar 25, 2011) |
| Status | Terminated |
| Reason | When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image, thus the line measurements may be inaccurate. |
| Root cause | Software design |
| Action | No consignee letter was sent out. FMI No. 25431 shows where the Field Engineer had to communicate with the hospital (Instead of them sending a letter). GE Healthcare has updated all of the affected Advantage Workstation systems affected by the GSI viewer issue. At this time, deployment of the recall is considered complete. As an effectiveness check, they have tracked all service requests for the field action to completion. These service requests record the repair of the affected units. Exceptions to completion of the service request have been recorded as well. Records of field action comple |
| Quantity | 283 (59 US, 224 OUS) |
| Distribution | Worldwide Distribution: US (nationwide): AL, AZ, CA, CT, FL, IL, IN, IA, KY, MD, MA, MI, MS, NV, NH, NJ, NY, PA, WA, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KUWAIT, LATVIA, NEW |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081105 | GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) GE Healthcare, May 9, 2008 |