GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.1
FDA device recall Z-1148-2014 · posted 2014-03-06 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 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.
- Action taken
- 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 completion will be retained per their processes and procedures.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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, FINLA
- Date initiated
- 2011-03-25
- Date posted
- 2014-03-06
- Date terminated
- 2014-03-13
- Location
- Waukesha, WI
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| GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) (K081105) | GE Healthcare | 2008-05-09 |