GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system. GE Healthcare Amer
FDA device recall Z-1088-2007 · posted 2007-09-28 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- The systems do not contain a certification label on the C2 Cabinet (Beam-limiting control).
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 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, Chin
- Date initiated
- 2006-06-06
- Date posted
- 2007-09-28
- Date terminated
- 2015-12-08
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVA 2100 (K050489) | Ge Medical Systems, LLC | 2005-03-11 |