Recall Z-0524-2014— GE OEC Medical Systems, Inc

Name: FDA recall Z-0524-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-26

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2013-11-26, terminated 2017-04-17. It names one FDA 510(k) clearance: K960330. Product: InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),. Reason: GE OEC Medical Systems Inc is recalling InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products..

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-11-26
Terminated: 2017-04-17
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K960330 — INSTATRAKVisualization Technology, Inc.·cleared 1996-04-08

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

InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),

Reason for recall

GE OEC Medical Systems Inc is recalling InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.

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