Recall Z-2161-2021— GE OEC Medical Systems, Inc
Class II · Terminated
Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2021-06-10, terminated 2024-05-09. It names 4 FDA 510(k) clearances: K192819, K172550, K171565 and 1 more. Product: 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.. 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..
- Recalling firm
- GE OEC Medical Systems, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-10
- Terminated
- 2024-05-09
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
4 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.