GE OEC Medical Systems, Inc: Medical Device Recall in 2013 - (Recall #: Z-0524-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 26, 2013

Date Posted: December 25, 2013

Recall Number: Z-0524-2014

Event ID: 66992

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.

Status: Terminated

Product Quantity: 654

Code Information:

Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated