Z-2388-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2018
- Initiation Date
- March 29, 2018
- Termination Date
- June 15, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102 devices total
Product Description
Discovery IGS 740 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 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.
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).