Z-1060-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2017
- Initiation Date
- December 27, 2016
- Termination Date
- July 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,256 total
Product Description
OEC 9900 Elite. MDL Numbers: D148942, D155043
Reason for Recall
GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.
Distribution Pattern
Worldwide including govt/VA/military and foreign consignees.
Code Information
Manufactured from Oct 2005 to present