FDA-Device2017-02-01Class II
OEC 9900 Elite. MDL Numbers: D148942, D155043
GE OEC Medical Systems, Inc
Hazard
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.
Sold states
Worldwide including govt/VA/military and foreign consignees.
Affected count
26,256 total
Manufactured in
384 N Wright Brothers Dr, N/A, Salt Lake City, UT, United States
Products
OEC 9900 Elite. MDL Numbers: D148942, D155043
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1060-2017Don't want to check this manually?
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