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U.S. Department of Health and Human Services

Enforcement Report - Week of November 20, 2013

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Product Detail

Product Description 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.
Recall Number Z-0270-2014
Classification Class II
Code Info 006 00000Q13022004 00000G10271002 00000G10271001 00000F10281001 0000AC12277003 0000AC12277001 00000M13123012 00000J13175001 00000U12263003 00000U12263002 00000A12174020 00000LA70A4A10 00000L3A5F3C9C 0000AL12233002 0000AL12233001 00000L020E0A85 0000AB12018004 00000Z13168003 00000Z13168002 0000AD12269003 0000AD12269002 00000LE4B6A1CA 00000L3AB2DE60 00000P11312012 0000AL12144002 000000G9337008 0000AM12208001 0000AP12123001 0000AQ11291001 00000T12333004 00000L3A73153D 00000P11312019 00000H13058001 0000AG12118006 00000X13036003 00000W13204008 0000AM12222004 0000AM12222003 00000A12219002 00000A12219001 00000R12086007 00000G13078002 00000G13078005 00000Z12251001 0000AP12123002 00000L02577B48 000000Z9350001 0000AE11294002 00000M13046005 00000LA712358B 00000W10202001 00000H10098001 00000A10194004 00000A10194003 00000A10194002 00000X13036001 00000T13044001 00000R13025001 00000Q13022007 00000P13088001 00000N13024002 00000L13171002 00000G13078003 0000AM12222002 00000LA70A48C3 0000AP12123004 0000AL12144004 00000L3A7315C1 0000AX12262003 0000AM12261001 00000S11020004 00000S11020001 00000N10337018 00000L3A5BF838 00000L3A79AB03 00000L3A5BF827 00000E10336003 00000L3A5BF84E 00000L3A75873B 00000L3A5BF911 00000L3A9CCE94 00000L3A77E646 00000N12146001 00000L8B19A930 0000AG12118002 0000AL12142001 00000X13036002 00000Y12317002 0000AD12202004 0000AC12353003 0000AC12353002 00000L3AB68E28 0000AJ12082001 0000AH12080001 0000AC12353001 00000L0257B583 00000M12048003 00000E12332006 000000L9343010 00000K13143003 00000K13143002 00000K13143001 00000N13024001 00000L10351001 00000H10085001 00000E12332010 0000AQ12290001 0000AN11298006 0000AD12125001 00000L3A5249E5 00000F12320001 00000X12244001 0000AE11234004 0000AD13072001 00000T13073003 00000T13073001 00000Q13074001 00000V10243002 00000V10243001 00000D10232001 00000Q13022006 00000N13064005 00000N13064001 00000N12348004 00000N10127004 00000J13063002 0000AB13113001 00000E12332007 00000L3AB68DBD 0000AC12130002 00000N12146006 00000N11159001 00000M13123005 00000M13123004 00000N10337013 00000N10337004 00000A12219006 00000A12219004 00000A12219003 00000L3AB1F8BA 00000L3A557466 0000AH12265006 00000LA704C005 0000AC13154006 00000Z13168001 00000L3A3C7D9D 00000W13115011 00000L3A9C8A55 00000L3A9C8A23 00000X11076002 00000X11076001 00000W13031001 00000Q11060001 00000N11028002 00000N11028001 00000M11069002 00000L3A70C8C6 00000N10337012 0000AL12142004 0000AL12142003 00000X12040003 00000X12040001 00000U10246001 00000N12348006 00000N12348005 00000L3A4F064F 00000L3A4F0555 00000AE9295001 0000AG12118005 0000AG12118004 0000AG12118003 00000P13151001 0000AD10244002 00000U10251002 00000F10229008 00000G10312004 00000G10312003 00000G10312001 00000W11054001 00000R11031001 00000M11069001 00000L3A2A1F16 00000L3A2A1F15 000000W9351001 00000L3AB68D9B 00000D12363002 00000D12363001 00000N11172003 00000N11172002 0000AL12233005 00000A12219009 00000A12219005 00000L022E5E3B 00000S11049002 00000R11052001 00000L3A2A2083 000000Z9309001 0000AL12142009 0000AE12041001 00000R11027005 00000R11027004 00000Q11070001 00000L3A4F066C 000000L9343001 00000W11054002 00000T11061003 00000T11061001 00000D11066001 00000332781GE4
Product Distributed Qty 1458 (336 US, 1122 OUS)
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 correct. The concern is that the patient right/left representation is from the Superior view, which could result in a misreading of the image and misdiagnosis.

Event Detail

Event Id 66550
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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. .
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