OEC 9800. MDL Numbers: D222250, D141598
FDA Recall #Z-1059-2017 — Class II — December 27, 2016
Product Description
OEC 9800. MDL Numbers: D222250, D141598
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.
Recalling Firm
GE OEC Medical Systems, Inc — Salt Lake City, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
26,256 total
Distribution
Worldwide including govt/VA/military and foreign consignees.
Code Information
Manufactured from Feb 1998 to present
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated