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U.S. Department of Health and Human Services

Class 2 Device Recall AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ O

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 Class 2 Recall
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ O
see related information
Date Posted November 13, 2013
Recall Status1 Terminated on July 31, 2014
Recall Number Z-0270-2014
Recall Event ID 66550
Premarket Notification
510(K) Numbers
K052995  K081985  K110834 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product 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 may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, 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 may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
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00000Q11070001 00000L3A4F066C 000000L9343001 00000W11054002 00000T11061003 00000T11061001 00000D11066001 00000332781GE4
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
DESIGN: 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 GE Healthcare service representative will contact you to arrange for this correction. This activity will be performed at no cost to you. A second updated letter was sent on October 22, 2013 to correct the Affected Product Details communicated in the previous letter dated September 19, 2013. The new statement reads "All versions of GSI Viewer prior to version 2.00-OM on AW and prior to version 2.20- OB on AW Server are affected". If you have any questions, please contact us at 800-437-1171 (USA and Canada) or contact local GE Healthcare Applications Specialist.
Quantity in Commerce 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, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HON KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LIBYA, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM. .
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE HEALTHCARE
510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS, LLC
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