—#103023

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.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K960265
Affected lot / code info: 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, 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Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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.

Timeline

Recall initiated: 2011-08-18
Posted by FDA: 2011-09-27
Terminated: 2012-08-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.