| Class 2 Device Recall GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Wor | |
Date Initiated by Firm | May 25, 2012 |
Date Posted | March 01, 2013 |
Recall Status1 |
Terminated 3 on January 28, 2014 |
Recall Number | Z-0901-2013 |
Recall Event ID |
64071 |
510(K)Number | K041521 K972399 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | 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. |
Code Information |
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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 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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 |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact | 262-513-4122 |
Manufacturer Reason for Recall | Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis. |
FDA Determined Cause 2 | Software design |
Action | GE Healthcare sent a "Urgent Medical Device Correction " letter dated May 23, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to discontinue use of the Edit Contour feature until this software functionality is corrected or replaced.
GE Healthcare will correct all affected systems by providing a software upgrade at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following phone numbers:
United States: 800 437 1171
Japan: 0120 - 055 - 919
For other countries, please contact your local GE Healthcare Service Representative. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above. |
Quantity in Commerce | 363 |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JAK 510(K)s with Product Code = JAK
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