Advantx-E is an angiographic X-Ray system.

FDA device recall Z-2038-2008 · posted 2008-09-16 · Terminated

Recall details

Recalling firm: GE Healthcare
Reason for recall: Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system
Action taken: Consignees were contacted by means of a Urgent Medical Device Correction letter dated 1/14/07. The letter is addressed to; Hospital Administrator, Hospital Risk Management Department, Manger of Radiology/Cardiology and Radiologists/Cardiologists. The letter describes the affected product and safety issue. The letter offers recommendations, solutions and provides contact information. If you have questions contact the firm: In the US contact the call center at 800-437-1171, option 4 and other countries should contact your local GE Healthcare field service representative.
Root cause: Process control
Status: Terminated
Product code: IZI
Quantity affected: 252
Distribution: USA: AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, OH OR, PA, SC, TN, TX, WI, AK, AL, AR, AZ, CT, DE, GA, HI, IA, ID, KS, KY,LA ME, MI, MN, MS, MT, ND, NE, NH, NY, OK, RI, UT, VA, WA, WI
Date initiated: 2008-01-14
Date posted: 2008-09-16
Date terminated: 2011-12-17
Location: Waukesha, WI

Recalls and clearances share one API, with change alerts when new recalls post.