FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
- Recall number
- Z-1469-2017
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
- Status
- Terminated
- Initiated
- 2017-02-21
- Posted
- 2017-02-27
- Terminated
- 2017-04-24
- Reason
- OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
- Root cause
- Process control
- Action
- On February 21, 2017, an Urgent Medical Device Correction letter was sent to one consignee with an affected unit; a field service representative hand delivered the customer communication.
- Quantity
- 1
- Distribution
- One consignee in CA.
- Lot, serial or model codes
- OEC FlexiView 8800 systems that had NEMA 5-15 15 Amp power cords replaced between January 28, 2016 and November 23, 2016.
- 510(k) numbers
- ["K003837"]
- PMA numbers
- not on file
- Product code
- OXO
- Firm FEI
- 1720753
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28