FDA-Device2018-07-18Class II
Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
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.
Sold states
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.
Affected count
102 devices total
Manufactured in
283 rue de la Miniere, Buc, France
Products
Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2386-2018Don't want to check this manually?
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