GE OEC Medical Systems, Inc Recall 88202
Description: OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures
GE OEC Medical Systems, Inc Recall 88202 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2160-2021 |
| Event ID | 88202 |
| Event Description | OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, PA, WA, OH, LA, MS, AL, FL, MO, OK, AZ, NJ, CO, MI, NV, MN, KS, TN, NC, IL, MD, SC,GA, UT, WI, MT, AR, WV, ID,CT, IA, WY, VT, KY, DC, SD,ME, Virgin Islands and the countries of Colombia, Egypt, Peru, Chile, Spain, France, Germany, Hong Kong, Canada, Japan, Brazil, Turkey, United Arab Emirates, Singapore, Australia, Thailand, United Kingdom, Italy, Korea, Russia, CHINA, Romania, Nigeria, Czechia, Argentina, Taiwan, Bangladeh, Malaysia, Bosnia and Herzegovina, Poland, Belgium, Indonesia, Dominican Republic, Switzerland, Hungary, New Zealand, Vietnam, Mexico, India, Norway, Philippines, Ecuador, Lithuania, HONDURAS, Uruguay, Sweden, Croatia, Jamaica, Kuwait, Ethiopia, Saudi Arabia, Finland, Bahamas, Trinidad and Tobago, Pakistan, Slovakia, Costa Rica, Israel, Panama, Greece, South Africa and DENMARK. |
| Quantity | 3 units |
| Recall Reason | There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable. |
| Device Classification | 20210804 |
| Device Code Info | All OEC 3D Systems |
| Center Classification Date | 20210729 |
| Recall Initiation Date | 20210610 |
| Recalling Firm | GE OEC Medical Systems, Inc |
| Initial Notification | Letter |
| Similar To |