GE OEC Medical Systems, Inc

4 FDA enforcement actions

4 Total Recalls

0 Class I

4 Class II

0 Class III

Firm Details

Product Types: device
States: UT

All Recalls

Class II: Risk 11/21/2024 device

Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Class II: Risk 11/21/2024 device

Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Class II: Risk 11/21/2024 device

Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Class II: Risk 11/21/2024 device

Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.