Recall Z-2628-2016— GE OEC Medical Systems, Inc

Name: FDA recall Z-2628-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-22

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2016-07-22, terminated 2016-12-19. It names one FDA 510(k) clearance: K993687. Product: OEC UroView 2800, fluoroscopic x-ray system. Reason: A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed..

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-22
Terminated: 2016-12-19
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K993687 — UROVIEW 2800Ge Dec Medical Systems·cleared 1999-12-21

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 UroView 2800, fluoroscopic x-ray system

Reason for recall

A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.

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