Recall Z-0193-2015— GE OEC Medical Systems, Inc

Name: FDA recall Z-0193-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-03

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2014-10-03, terminated 2015-03-23. It names one FDA 510(k) clearance: K992506. Product: OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.. Reason: GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems..

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-10-03
Terminated: 2015-03-23
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K992506 — MINI 6800 DIGITAL MOBILE C-ARMGe Dec Medical Systems·cleared 1999-08-19

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¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.

Reason for recall

GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.

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