Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and versio

FDA device recall Z-0560-2013 · posted 2012-12-19 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE 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

Action taken

GE 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 the entire branch, not only the final end-point. 4. When analyzing multi-phase cardiac images, do not delete vessel branches from a phase other than the one in which it was created. Customers were instructed that the new application version that addresses this issue will soon be installed on all systems. Customers with questions or concerns were instructed to call the following: United States 1-800-437-1171. Japan 0120-055-919 For other countries they were instructed to contact their GE Healthcare Service Representative. For questions regarding this recalla call 262-513-4122

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

548 (118 USA; 430 OUS)

Distribution

Worldwide 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

Date initiated

2012-05-29

Date posted

2012-12-19

Date terminated

2013-01-17

Location

Waukesha, WI