PlainRecalls
FDA Devices Moderate Class II Terminated

Discovery IGS 730 Interventional Fluoroscopic X-ray Systems

Reported: July 18, 2018 Initiated: March 29, 2018 #Z-2386-2018

Product Description

Discovery IGS 730 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.

Details

Recalling Firm
GE Medical Systems, SCS
Units Affected
102 devices total
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.
Location
Buc

Frequently Asked Questions

What product was recalled?
Discovery IGS 730 Interventional Fluoroscopic X-ray Systems. Recalled by GE Medical Systems, SCS. Units affected: 102 devices total.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 18, 2018. Severity: Moderate. Recall number: Z-2386-2018.