Recall Z-2161-2021 ยท OWB Interventional Fluoroscopic X-Ray System
GE OEC Medical Systems, Inc
OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
| Date | Jun 10, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On June 11, 2021, GE Healthcare issued an "Urgent Medical Device Correction via certified mail to all affected consignees. In addition to informing consignees about the recalled product, the firm asked customers to take the following actions: 1. You may continue to use your system. 2. Please disseminate this information to applicable users within your facility. 3. When the system is not in use, it is recommended to connect the system to power with the workstation plugged in and the interconnect cable attached to the mainframe, to reduce potential battery depletion. It is not necessary to t |
| Quantity | 3570 units |
| 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, Fra |
| FDA record | Open on fda.gov |