Recall Z-1059-2017— GE OEC Medical Systems, Inc

Name: FDA recall Z-1059-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-27

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2016-12-27, terminated 2018-07-12. It names 2 FDA 510(k) clearances: K132027, K111551. Product: OEC 9800. MDL Numbers: D222250, D141598. Reason: 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
Classification: Class II
Status: Terminated
Initiated: 2016-12-27
Terminated: 2018-07-12
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

2 on FDA's record

K132027 — OEC 9800 PLUSGe Oec Medical Systems, Inc.·cleared 2014-05-01
K111551 — OEC(R) 9800, OEC(R) 9800 PLUSGe Oec Medical Systems, Inc.·cleared 2011-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.