GE Healthcare Advantage Workstations…

Date posted by the FDA

Nov. 28, 2007

Status

Terminated

Filed by

GE Healthcare

Product

GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Worksation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2,GE Healthcare, Waukesha, WI. 53188

Reason

Aortic Length over-estimated: incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed the aorta analysis protocol or the customized protocols for an aneurysm should NOT BE USED.

Distribution pattern

Worldwide Distribution - USA including states of AK, AL, AR, AZ, CA, CO, CT, CU, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Guam, and countries of Canada, Mexico. Argentina, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Australia, China, Honk Kong, Indonesia, Japan, Korea, New Zealand, Singapore, Thailand, Taiwan, United Arab Emirates, Albania, Austria, Azerbaijan, Bosnia, Belgium, Belarus, Switzerland, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Guadeloupe, Greece, Hungary , Ireland, Israel, Italy, Kuwait, Lebanon, Morocco, Netherlands, Norway, French Polynesia, Poland, Portugal, Russian Federation, Saudi Arabia, Sweden, Slovenia, Tunisia, Turkey, and South Africa.

Quantity

2,518

Codes and lots

Model 2378698-2 Serial #: 00000048570GE6 00000026242GE8 00000021465GE0 00000057141GE4 00000080246GE2 00000082828GE5 00000021776GE0 00000022426GE1 00000017866GE5 00000015743GE8 00000009840GE0 00000056383GE3 00000060521GE2 00000080136GE5 00000054095GE5 00000020473AW5 00000066933GE3 00000056368GE4 00000061919GE7 00000068157GE7 00000009838GE4 00000049905GE3 00000063495GE6 00000070180GE5 00000061922GE1 00000061923GE9 00000022425GE3 00000023775GE0 00000018684GE1 00000014239GE8 00000016974GE8 00000020873GE6 00000028471GE1 00000056378GE3 00000014233GE1 00000020982GE5 00000009846GE7 00000033292AW4 00000024404GE6 00000025815GE2 00000020438AW8 00000014238GE0 00000059320GE2 00000055098GE8 00000019216GE1 00000029213GE6 00000069440GE6 00000069439GE8 00000022427GE9 00000066941GE6 00000486421BU1 00000027277AW3 00000027276AW5 00000052488AW4 00000062286GE0 00000072425GE2 00000020300GE0 00000020974GE2 00000012226GE7 00000012225GE9 00000011140GE1 00000011138GE5 00000011139GE3 00000011136GE9 00000015741GE2 00000017862GE4 00000019219GE5 00000022424GE6 00000052451GE2 00000087148GE3 00000020409AW9 00000059324GE4 00000078059GE3 00000078058GE5 00000081171GE1 00000070183GE9 00000069445GE5 00000030200GE0 00000027284AW9 00000036826AW6 00000020443AW8 00000030123AW4 00000070187GE0 00000024210AW7 00000020426AW3 00000020983GE3 00000023786GE7 00000014235GE6 00000022412GE1 00000058138GE9 00000030067AW3 00000030070AW7 00000030083AW0 00000023771GE9 00000058123GE1 00000023770GE1 00000058133GE0 00000066940GE8 00000058135GE5 00000069448GE9 00000058122GE3 00000023773GE5 00000058134GE8 00000081877GE3 00000068164GE3 00000019314GE4 00000024412GE9 00000024409GE5 00000061909GE8 00000078730GE9 00000026247GE7 00000029208GE6 00000030205GE9 00000042039GE8 00000052958GE6 00000059321GE0 00000016374GE1 00000024420GE2 00000076621GE2 00000076195GE7 00000080740GE4 00000080746GE1 00000061911GE4 00000078729GE1 00000040372GE5 00000048569GE8 00000076196GE5 00000027389GE6 00000037147GE6 00000020406AW5 00000047194GE6 00000057155GE4 00000047197GE9 00000018675GE9 00000049904GE6 00000049903GE8 00000019310GE2 00000065283GE4 00000010743GE3 00000010744GE1 00000047199GE5 00000020872GE8 00000047193GE8 00000025406GE0 00000027398GE7 00000026604GE9 00000026605GE6 00000027402GE7 00000018359AW0 00000057148GE9 00000070852GE9 00000009843GE4 00000042038GE0 00000044314GE3 00000047188GE8 00000045183GE1 00000037458GE7 00000059329GE3 00000010384GE6 00000017856GE6 00000044211GE1 00000054097GE1 00000051797GE9 00000039602GE8 00000039604GE4 00000035037GE1 00000063507GE8 00000075389GE7 00000055104GE4 00000078060GE1 00000035038GE9 00000046334GE9 00000054093GE0 00000034345GE9 00000025419GE3 00000065288GE3 00000061914GE8 00000035129GE6 00000049915GE2 00000086697GE0 00000060837GE2 00000047613GE5 00000018670GE0 00000029207GE8 00000046326GE5 00000047609GE3 00000033939GE0 00000021467GE6 00000051141GE0 00000044213GE7 00000045187GE2 00000047608GE5 00000014231GE5 00000014230GE7 00000014232GE3 00000087646GE6 00000055093GE9 00000055100GE2…

Recall started

Sept. 10, 2007

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

An Urgent Safety Notice to customers dated 9/10/07, was issued by the recalling firm informing them of the device defect, safety issues, warnings on future uses and promised new software updates to be installed by GE representatives, free of charge, beginning Nov. 2007.

Recall number

Z-0265-2008

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

Source: FDA · Medical device enforcement report, recall number Z-0265-2008. The agency record governs; check it and the company before acting.