Device product
Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
Z-2388-2018
Product summary
- Event
- Event 80177
- Status
- Terminated
- Classification
- Class II
- Quantity
- 102 devices total
- Official record key
device-enforcement:Z-2388-2018
Official wording
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.
Code information: Model Number 5730891- Lot Number (System ID): 00000D4-17-029 (478765NSP), 00000D4-17-031 (712279DIS), 00000D4-17-030 (716845DISC), 00000D4-18-003 (951TVHDISC740), 00000D4-18-001 (352751DISC), 00000D4-17-032 (SA1011VA02); Model Number 5759342 - 00000D4-17-028 (GON 4610398).
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.