Z-1469-2017 Class II Terminated
FDA device recall Z-1469-2017 was initiated by GE OEC Medical Systems, Inc on February 21, 2017 and is designated Class II. 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. The recall status is terminated (terminated April 24, 2017). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2017
- Initiation Date
- February 21, 2017
- Termination Date
- April 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
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.
Distribution Pattern
One consignee in CA.
Code Information
OEC FlexiView 8800 systems that had NEMA 5-15 15 Amp power cords replaced between January 28, 2016 and November 23, 2016.