ClearanceBrief
Recall Z-0560-2013 ยท LLZ System, Image Processing, Radiological

GE Healthcare, LLC

Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or SPECT Advantage Workstations Volume Share (v.AW4.3) and AW4.2 (version4.2-05 and above) provided with Volume Viewer 2(versi

DateDec 19, 2012 (initiated May 29, 2012)
StatusTerminated
ReasonGE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety. 2) A refresh problem of the stenosis / aneurysm measurement tools associated with the cardio-vascular applications of
Root causeSoftware design
ActionGE Healthcare sent two Urgent Medical Device Correction letters dated May 23, 2012, to all affected customers. Each letter addressed a separate issue. The letters described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. Customers were instructed to use the following precautions until corrected software was installed: 1. Please avoid the use of leading or trailing spaces in Vessel Names 2. Be sure to press "Show Tracking" after depositing new bifurcation points 3. When eating a multi-point vessel tracking, remove and replace t
Quantity548 (118 USA; 430 OUS)
DistributionWorldwide Distribution - USA including AL, CA, CO, FL, GA, IL, IN, IA, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX , UT, VA, WI and Internationally to the following countries: VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, TAIWAN, SWIT
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.