Recall Z-0974-2017— GE OEC Medical Systems, Inc

Name: FDA recall Z-0974-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-19

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2016-12-19, terminated 2017-08-22. It names one FDA 510(k) clearance: K992506. Product: OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 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 Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures..

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-12-19
Terminated: 2017-08-22
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. MDL Number: D002533 The OEC MiniView 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 Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

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