Recall Z-0270-2014 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor ma
| Date | Nov 13, 2013 (initiated Sep 19, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correc |
| Root cause | Software design |
| Action | The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated September 19, 2013 to its consignees/customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (800-437-1171 for USA and Canada or contact local GE Healthcare Applications Specialist). The customers were instructed to "Please ensure that all potential users in your facility are made aware of this safety notification and the action taken". GE Healthcare will provide a software update for all affected systems to address the issue. A G |
| Quantity | 1458 (336 US, 1122 OUS) |
| Distribution | Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT,DE, FL,GA, HI, IL, IN, IA, KS, MD,MA, MI,MN, MS, O. NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX , UT, VA, WA, WI. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BYELO RUSSIAN, CANADA, CHINA, DENMARK, ESTONI |
| FDA record | Open on fda.gov |