Recall Z-1088-2007 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Healthcare
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.
| Date | Sep 28, 2007 (initiated Jun 6, 2006) |
| Status | Terminated |
| Reason | The systems do not contain a certification label on the C2 Cabinet (Beam-limiting control). |
| Root cause | Other |
| Action | Starting on June 6, 2007, a GE service engineer will go to each affected site to affix certification labels on the affected devices. |
| Quantity | 161 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050489 | INNOVA 2100 Ge Medical Systems, LLC, Mar 11, 2005 |