FDA recall Z-2387-2018

Product

Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems

Reason for recall

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2018-03-29

Report date

2018-07-18

Termination date

2021-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buc, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2387-2018