ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems…

Date posted by the FDA

Sept. 27, 2011

Status

Terminated

Filed by

GE Healthcare, LLC

Product

ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems, SCS. A software module that provides supplemental information to those images extracted from CT and MR temporal datasets.

Reason

GE Healthcare has become aware that image orientation of reference series displayed in Functool Diffusion Tensor/FiberTrak protocol on Advantage Workstation may not match with the orientation annotations displayed in the viewport. This issue may impact patient safety.

Distribution pattern

Worldwide Distribution: Nationwide distribution including the states of AZ, CA, CT, DC, FL, ID, IL, KY, LA, MD, MI, MN, NJ, NY, OR, PA, PR, TN, TX, VA, WA, and WI; and the countries of VIETNAM, MEXICO, UNITED KINGDOM, TURKEY, TUNISIA, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, ST HELENA, SPAIN, SLOVENIA, SINGAPORE, SAUDI ARABIA, RUSSIAN F¿D¿RATION, ROMANIA, REUNION, REPUBLIC OF CHINA, QATAR, PORTUGAL POLAND, PARAGUAY, NETHERLANDS, MOROCCO, MALAYSIA, MACEDONIA, LUXEMBOURG, LIBYA, KUWAIT, KOREA, JAPAN, ITALY, ISRAEL, INDONESIA, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, CZECH REPUBLIC, CROATIA, COSTA RICA, COLOMBIA, CHILE, CANADA, BELARUS, BRAZIL, BOSNIA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA, and ARGENTINA.

Quantity

697

Codes and lots

Serial Numbers: 00000156053GE1, 00000156054GE9, 00000160141GE8, 00000160142GE6, 00000163510GE1, 00000177462GE9, 00000177463GE7, 00000178185GE5, 00000181683GE4, 00000188460GE0, 00000190791GE4, 00000193324GE1, 00000197286GE8, 00000197290GE0, 00000199300GE5, 00000211314GE0, 00000213647GE1, 00000224809GE4, 00000224810GE2, 00000235766GE3, 00000154900GE5, 00000156057GE2, 00000163515GE0, 00000174344GE2, 00000176430GE7, 00000177464GE5, 00000183715GE2, 00000190793GE0, 00000197289GE2, 00000202806GE6, 00000211312GE4, 00000224811GE0, 00000230390GE7, 00000230391GE5, 00000235769GE7, 00000239644GE8, 00000B10232002, 00000R10048002, 00000S10145004, 00000Z11048001, 00000P10256003, 00000S10349006, 00000Y11012001, 000000U9229001, 0000AD11124002, 0000AH11070001, 00000E10344008, 000000F9146004, 000000F9146006, 000000R9210001, 000000R9250003, 0000AG11102002, 0000ZD10349001, 00000F10186001, 00000R11013001, 00000S11004001, 00000T11062001, 00000U11056001, 000000L9299001, 000000Q9349002, 000000T9285001, 00000C11167002, 00000P10137001, 00000R10117001, 00000H10158001, 00000K10140002, 00000X10159002, 00000Z10067005, 00000E10344005, 00000AB9251002, 00000D10210004, 00000K10020008, 00000T10224001, 000000V9254002, 0000AG11073001, 0000AB10071002, 00000F10249005, 00000L10334006, 00000X10159001, 000000Q9302002, 000000R9323002, 0000AD10327005, 0000AD10327006, 00000Z10333001, 0000AE10155002, 00000D10071005, 00000K10020005, 00000T10033007, 000000L9299003, 0000AD10245001, 0000AD11096001, 00000S11011001, 00000E10069003, 00000L10334003, 00000R10168002, 000000F9175001, 0000AP11119001, 00000D10210002, 00000E10344010, 00000K10020003, 00000L10334001, 00000N10116001, 00000P10050001, 00000P10356001, 00000P10357002, 00000Q10285001, 00000S10349005, 00000S11004002, 00000S11011006, 00000S11011007, 00000U10350001, 00000W10167002, 000000Q9281002, 000000U9204001, 000000W9257004, 000000Z9191001, 00000S11150001, 000000Z9202001, 00000AB9251001, 00000AB9251003, 00000S11011003, 000000K9082005, 00000L11132001, 00000M10057002, 00000V10055001, 0000AG10307003, 00000T11038001, 00000T11038002, 00000X11031002, 00000X11031003, 0000AH11152002, 0000AH11152003, 00000A10222002, 00000V10130002, 00000Z10264001, 0000AD10245006, 00000Z11111001, 000000S9217001, 00000X11125001, 000000P9307004, 00000H10309005, 00000S11060001, 000000X9131001, 0000AA10182001, 0000AA10243001, 0000AA10330001, 0000AD10230003, 0000AD10245004, 0000AD10245005, 0000AD10250001, 0000AD10327002, 0000AD10327004, 0000AE10155001, 0000AG10307001, 0000AG10307004, 0000AH10126001, 0000AM10244001, 0000ZF10239001, 00000AB9244001, 00000B10232001, 00000B10232004, 00000B10232005, 00000D10071001, 00000E10069001, 00000E10139001, 00000E10139002, 00000E10344006, 00000E10344007, 00000E10344011, 00000E10344012, 00000F10249001, 00000F10249009, 00000H10309003, 00000H10309004, 00000H10309010, 00000J10180001, 00000J10252001, 00000K10020009, 00000K10118003, 00000K10147001, 00000K10338003, 00000K10338005, 00000K10338006, 00000K10338007, 00000K10338008, 00000L10015002…

Recall started

Aug. 18, 2011

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

GE Healthcare sent "Urgent Medical Device Correction" letters dated August 18, 2011 to all affected customers. The letter included name of product affected and described problem. Recommended actions where provided to customers and they were notified a GE Healthcare representative will contact them for a software system upgrade. For question of this recall contact the GE Service Representative at (800) 437-1171.

Recall number

Z-3282-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-3282-2011. The agency record governs; check it and the company before acting.