GE Medical Systems, SCS recalls Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems

Recall date

March 29, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2387-2018

FDA classification

Class II

Brand / firm

GE Medical Systems, SCS

Sold / distributed

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,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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