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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Event Detail

Event ID 64071
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-25
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA including the states of AR, CA, CO, FL, GA, IL IN, IA, LA, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX and VA. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, ARGENTINA, BELARUS, CANADA, CHINA, CHILE, EGYPT CZECH REPUBLIC, FRANCE, FINLAND, GERMANY, GABON, HONG KONG, INDIA, IRELAND, ITALY KENYA, KOREA, JAPAN, MEXICO, NIGERIA, PHILIPPINES, PORTUGAL REPUBLIC OF MALTA, RUSSIAN FEDERATION SAUDI ARABIA, SPAIN SWITZERLAND, TURKEY, TAIWAN, TUNISIA, UNTIED KINGDOM and VENEZUELA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning. 000000010009GS 000000010017GS 000000010049GS 000000010045GS 000000010001GS 000000010030GS 000000010004GS 000000010062GS 000000010054GS 000000010028GS 000000010005GS 000000010086GS 000000010002GS 00000L026FFE60 00000L0271A594 000000010081GS 000000010041GS 000000010024GS 000000010026GS 000000010043GS 000000010072GS 000000010079GS 000000010082GS 000000010057GS 000000010051GS 000000010071GS 000000010064GS 000000010073GS 000000010077GS 000000010038GS 000000010053GS 000000010047GS 000000010033GS 000000010094GS 000000010050GS 000000010021GS 000000010015GS 00000L0219C835 000000010059GS 000000010012GS 000000010018GS 000000010060GS 000000010003GS 000000010008GS 000000010014GS 000000010020GS 000000010075GS 000000010074GS 00000L0274A04C 000000010022GS 000000010048GS 000000010067GS 000000010063GS 000000010087GS 000000010034GS 000000010083GS 000000010036GS 000000010080GS 000000010044GS 000000010006GS 000000010068GS 000000010027GS 000000010091GS 000000010032GS 000000010029GS 000000010078GS 000000010007GS 000000010013GS 000000010090GS 000000010065GS 000000010016GS 000000010055GS 000000010069GS 000000010076GS 000000010052GS 000000010025GS 000000010092GS 000000010070GS 000000010089GS 000000010046GS 00000LEE1BC41D 000000010042GS 000000010061GS 000000010066GS 00000L0236B9CE 00000LEE1BC908 00000L023A0E34 00000L02019460 00000L02019ABA 00000L025B5C0C 00000LEE17087C 00000L610029DF 00000LEE1A72F8 00000L02374674 00000L025871B4 00000LEE1AA670 00000L6100BCF6 00000L61009728 00000L02167EAD 00000LEE1AD7CE 00000LEE170AEC 00000L6100B3FF 00000L6100C191 00000L022E0038 00000L0237474C 00000LEE1AD631 00000LEE1BC30A 00000L0235D1DC 00000L6100C520 00000L6100B968 00000L6100BCA9 00000L0265F43C 00000L6100BE7F 00000L0201485E 00000L0236B9CC 00000L0268E922 00000L020730A2 00000L0233B384 00000L025ADA52 00000L6100C4DC 00000L6100974C 00000L6100B69C 00000L0207263E 00000L6100BFE0 00000L0201994E 00000LEE1AD74B 00000L0235B34E 00000L025A17EE 00000LEE1AD7CD 00000L6100C4E1 00000L61009E1D 00000L0201521E 00000LEE170AC1 00000L0265F603 00000L0265FAEC 00000LEE1AD80B 00000L02227888 00000L0238B3C6 00000L0221F956 00000L0265F49B 00000L0238A6EA 00000LEE1741C5 00000L0238ABCE 00000L022282A4 00000L0265F218 00000L0265F118 00000L02227A88 00000L0238A6C8 00000L023709DA 00000LEE1A7313 00000LEE1A778D 00000LEE1F850E 00000L0238A8CC 00000L02370878 00000L0265F5F3 00000L02694970 00000LEE1AD897 00000LEE1AD89D 00000L0221F4EA 00000L0265F384 00000L023A0C44 00000LEE170AA3 00000LEE1A7493 00000L02370908 00000LEE1A772D 00000L6100C482 00000L6100C7CC 00000L6100C7D0 00000L02019A02 00000L5ED7239A 00000L61008DEF 00000L6100BEC6 00000LEE1AA6A4 00000L0264CDCE 00000L02370796 00000L02227774 000D1L02387E4E 00000L02387E4E 00000L6100BC64 00000L6100B661 00000L0238B020 00000LEE1B98A5 00000L5ED79164 00000L020149E4 00000L0221EBAC 00000L61008C51 00000L0265F035 00000L0221ED60 00000LEE17097B 00000L0265F1AC 00000LEE1B0982 00000L0222753C 00000L023A0E2C 00000L0235BB78 00000L0238AFC2 00000L026949B2 00000L0235D658 00000L0235B396 00000L6100BCE4 00000L6100BEC5 00000L6100BC5D 00000L6100B358 00000L02387E54 00000LEE1AD48B 00000LEE1741D8 00000LEE19B6E8 00000L6100BD8E 00000LEE1AD504 00000L025B532F 00000L02019690 00000LEE174318 00000LEE1FE40B 00000LEE1F861B 00000LEE1A7347 00000LEE1BC478 00000L023709D2 00000L02694A33 00000LEE17423B 00000L6100C802 00000L0265F383 00000LEE1BC55D 00000L0269496D 00000L02227AFA 00000L6100B85D 00000L022273F4 00000L0235CE3E 00000LEE1FE967 00000L0222740C 00000L0265FAEB 00000L0236B6DA 00000L023A0D8A 00000L0238B094 00000L6100B1CC 21288THHERA MR4-AW40 210572AW42 225358AWW ALLSIG429AW 505492AW1 931438LAWS1 225LSUAWW WS98556 WS132189 630325AW 515424PC1 210292AW42A SHAREDPETAW2 845368AW 870972CTAW 412825AW2 716859AW1 210297AW42A 317630AW2 301896SENOAW1 716887AW2 DZ1057AW02 DZ1193AW01 DZ1193AW03 DZ1193AW02 AWCT42 0910556069 BY4006AW02 BY4006AW01 BY4001AW04 BY4001AW03 416340AW05 082421030253AW 082416040015AW 082421020109AW 082427040070AW 082421040161AW1 082427040066AW 082421150078AW 082427150022AW 082421210168AW 082421110051AW 082416210002AW 082445060002AW 082421120200AW 082427120044AW 082427020022AW 082445040002AW 082427100064AW 082445130005AW 082427130022AW 082416130019AW 082427130030AW 082427080016AW 082421270070AW 082427140024AW 082427140037AW 082421140158AW 082421140155 Not Available EG1103AW01 FI1003AW09 X90281602 M4216023 HC1711AW01 470240AW01 UHAN01AW11 HPAD01AW01 467946AW01 CC0618AW10 0828210061AW02 0828210061AW01 0828210046AW03 083049006211046 083028552566875 083055062100555 083049862100445 083049802100636 083049822280910 083049822101866 083055602200145 083049242101006 083049802100535 083049842100015 IE1028AW04 IE1053AW02 A5375120 A5236222 A5719817 A126322004 D5249933 A5401537 A5696307 PY0132 0850210582AW1 5272AW42 8346ADW41 311AW2601238 NG1024AW01 0843490011 PL1493AW01 PL1124AW01 PL1622AW02 PL1584AW01 PPR83708 PPR62202 PPR83607 SA1006AW04 SA1007AW02 SA1283AW01 SA2079AW01 ZA1006AW01 CE557022 DED64778 EE214310 ME504368 FPG72503 CPM80622 DPM19608 FP180608 CEE15656 NE651510 NP384112 41018DCS01 53004DCS01 05004DCS01 00192ADW12 70772ADW01 38824624IISOCC Class II Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis. 363 Z-0901-2013
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