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Terminated

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

FDA Recall Z-0265-2008 · Posted 2007-11-28

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeLLZ
Date Initiated2007-09-10
Date Terminated2011-12-17
Product Quantity2,518

Reason for Recall

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.

Firm Action

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.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052995ADVANTAGE WORKSTATION 4.3.GE Healthcare · 2005-11-08K020483ADVANTAGE WORKSTATION 4.1GE Medical Systems · 2002-02-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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