Recall Z-2388-2018 ยท OWB Interventional Fluoroscopic X-Ray System
GE Medical Systems, SCS
Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
| Date | Oct 5, 2018 (initiated Mar 29, 2018) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | GE Healthcare notified customers on approximately 03/29/2018, via an URGENT MEDICAL DEVICE CORRECTION letter. Safety instructions included that before each use, to ensure the IGS system is fully functional as indicated in the GE product labeling and follow each facility's established procedures before and during each use to manage the patient if a repeated X-ray abort error occurs during the procedure or in the case a complete loss of fluoroscopic viewing capability may occur. If the problem persists, customers are instructed to contact their local GE Healthcare Service Representative. Add |
| Quantity | 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, Tunisi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133278 | DISCOVERY IGS 740 GE Medical Systems SCS, Apr 24, 2014 |