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.
FDA Recall Z-1088-2007 · Posted 2007-09-28
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeMQB
Date Initiated2006-06-06
Date Terminated2015-12-08
Product Quantity161
Reason for Recall
The systems do not contain a certification label on the C2 Cabinet (Beam-limiting control).
Firm Action
Starting on June 6, 2007, a GE service engineer will go to each affected site to affix certification labels on the affected devices.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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