GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system. GE Healthcare Americas P.O.Box 414, Milwaukee, Wisconsin 53201, U.S.A.
This recall has been terminated (originally issued September 28, 2007).
- Company
- Ge Healthcare
- Recall Initiated
- June 6, 2006
- Posted
- September 28, 2007
- Terminated
- December 8, 2015
- Recall Number
- Z-1088-2007
- Quantity
- 161
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
The systems do not contain a certification label on the C2 Cabinet (Beam-limiting control).
Distribution
World wide Distribution includes: AL, AR, AZ, CA,, CO, CT FL, GA, HI, ID, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI,and WV, and countries of ; Algeria, Australia, China, Denmark, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Kuwait, Latvia, New Zealand, Norway, Poland, Saudi Arabia, Singapore, Switzerland, Syrian Arab Republic, Turkey, and United Kingdom.
Lot / Code Info
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Root Cause
Other
Action Taken
Starting on June 6, 2007, a GE service engineer will go to each affected site to affix certification labels on the affected devices.