OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- February 21, 2017
- Posted
- February 27, 2017
- Terminated
- April 24, 2017
- Recall Number
- Z-1469-2017
- Quantity
- 1
- Firm Location
- Salt Lake City, UT
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.
Distribution
One consignee in CA.
Lot / Code Info
OEC FlexiView 8800 systems that had NEMA 5-15 15 Amp power cords replaced between January 28, 2016 and November 23, 2016.
Root Cause
Process control
Action Taken
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.
More recalls by Ge Oec Medical Systems, Inc
OEC 3D REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopi...
Dec 18, 2024
OEC 9800 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed...
Dec 18, 2024
OEC 9900 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoro...
Dec 18, 2024
OEC Elite REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is i...
Dec 18, 2024
OEC 9800 Systems with 9-inch Image Intensifier
Jul 31, 2023