Recall Z-1469-2017— GE OEC Medical Systems, Inc
Class II · Terminated
Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2017-02-21, terminated 2017-04-24. It names one FDA 510(k) clearance: K003837. Product: OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems. Reason: OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures..
- Recalling firm
- GE OEC Medical Systems, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-21
- Terminated
- 2017-04-24
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 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 FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
Reason for recall
OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
Data sourced from openFDA. This site is unofficial and independent of the FDA.