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GE Medical Systems, SCS recalls Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
Recalled July 18, 2018 · FDA recall Z-2388-2018 · GE Medical Systems, SCS
Hazard
The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use. · FDA Class II
Units
102 devices total
Sold at
US distribution: AR, CA, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, A,WI, WV. International Distribution: Argentina, Brazil, China, Colombia, Egypt, France, India, Indonesia, Iran, Italy, Japan, Kuwait, Lithuania, Myanmar, Palestine, Poland, Russia, Saudi Arabia, Singapore, Spain, Tunisia, Turkey, United Kingdom, Vietnam.
Description
The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
Product
Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
Manufacturer(s)
GE Medical Systems, SCS
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →