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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 001 00000L10351002 00000C10363001 00000U11174002 00000U11174001 00000L10351003 00000S11287002 00000S11287001 00000V10245006 00000N11172001 00000S11222002 00000T12333001 00000S11222006 00000N13163002 00000L13122001 00000V10245001 00000T12334008 00000T12334005 00000X11354003 00000R13025002 00000P11146002 00000R10250001 00000M13123010 00000M13123009 00000M13123008 00000M13123007 00000S11222005 00000S11222003 0000AB10235006 00000N11028004 00000N11159008 00000N11159002 00000R11166005 00000R11166001 00000N11159006 00000H11147006 00000N12146004 00000N12146003 00000T13081001 0000AE11203001 00000R11027002 00000K13008003 00000K13008001 0000AB10235002 00000W11112005 00000R11166003 00000R11166002 0000AJ12167002 0000AG12165002 00000M13046004 00000S12349001 00000P13042002 00000L13171001 00000F12030004 00000F12030001 00000P11312011 00000P11312006 00000R13017001 00000K12097001 0000AF12258001 00000Z12251002 00000P12242005 0000AB10235003 00000N10260002 00000T12032010 00000Q12067001 00000V10245003 00000T10291002 00000N10260001 00000G10307001 00000L3A9C89CE 0000AL12144006 0000AL12144003 00000N12146012 00000N12146005 00000W10349002 00000M11265005 00000M11265003 00000X11354002 00000V11083001 0000AE11234001 0000AA11243003 00000R11202002 00000R11202001 00000Q11173004 00000Q11173003 00000G11175002 00000X13107002 00000W13115003 00000P13087002 00000G13078001 00000Z12158001 00000M12157004 00000M12157003 00000Z12166003 0000AC13154001 0000AA11243002 00000C12070001 0000AF13080001 00000G13078004 0000AC13154002 00000W11328005 00000W11328007 0000AD12125006 0000AC12130004 S082421120267A 0S082421120267 00000L3A4817AE 00000W10125001 00000R11042001 00000M11045002 00000L10351006 00000L13023001 00000N11105001 00000L3A620C24 00000W12346001 00000W11328006 00000W11328004 00000N12146002 0000AB12083003 00000Z12093002 00000Z12093001 00000R12086009 00000W13115007 00000P13170002 00000B11095001 00000P11312016 00000M13046002 00000Y11250001 00000Y12340002 00000T13077001 0000AM12303002 00000B12305002 00000W11328009 00000T12338001 00000P11312001 00000M13123001 00000T13073005 0000AC12254001 00000I13066001 00000H13039001 00000T12334003 00000R13018002 00000R10250002 00000V10245007 00000D10252002 00000X10350004 00000W10349001 00000L3A443C8F 00000L3A443C82 00000N12348003 00000N12348002 00000N12348001 00000V10245004 00000E10265003 00000E10265002 0000ZA10223001 00000E10265001 0000AG10264001 00000V10245008 00000L10277001 00000J13127002 0000AM11355001 00000X11354001 00000N11330002 00000B11131009 00000Y12317001 00000N13014002 00000L13134010 00000L13134002 00000W11054003 00000J13063001 00000LA713461D 00000M13123006 0000AD12269001 00000S12271001 00000N13014001 00000L13011001 00000X12244002 00000W11101002 00000W11101001 00000J11077003 00000P12242002 00000N12348007 00000U13043002 00000U13043001 00000P13042001 00000N11102001 00000B11131007 00000B11131002 0000AC13154003 0000AE12247001 0000AB10235005 00000T12334007 00000T12334006 00000T12334004 00000T12334002 00000M13065002 00000U13185001 00000S13156002 00000S13156001 00000Z12158002 00000N12146009 00000N12146008 00000L3A9C88B6 00000Q11173002 00000B11131006 0000AF13149001 00000Z12251003 00000X12255002 00000S11020003 00000J11024001 00000P13087001 00000N13093001 0000AM11355002 00000R11353001 00000L3AA5ADDB 0000AZ12227001 00000X12255003 00000Z12251004 000000G9337004 00000Y12172003 00000Y12172002 00000Y12172001 00000F12320005 00000F12320002 00000B11131001 0000AM12222001 0000AA12221002 0000AA12221001 00000F12320010 0000AM12303007 0000AM12303006 00000F12320009 00000F12320007 00000E10011005 00000E10011004 00000E10011002 00000E10011001 00000S12328003 00000S12328002 00000S12328001 00000F12320006 00000F12320004 0000AE11294001 00000T12032004 00000S11019010 00000S11019009 00000S11019002 00000R11020005 00000Q11060
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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