GE OEC Medical Systems, Inc recalls OEC 9900 Elite. MDL Numbers: D148942, D155043

Recall date

December 27, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1060-2017

FDA classification

Class II

Brand / firm

GE OEC Medical Systems, Inc

Sold / distributed

Worldwide including govt/VA/military and foreign consignees.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

OEC 9900 Elite. MDL Numbers: D148942, D155043