Z-0524-2014Class II

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

Name: Z-0524-2014 InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA)
Creator: GE OEC Medical Systems, Inc
Published: 2013-11-26
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-11-26 / Terminated / root cause: software

FDA source

GE OEC Medical Systems, Inc began a recall of InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) on 2013-11-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0524-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-26
Posted: 2013-12-17
Terminated: 2017-04-17
Recalling firm: GE Healthcare
Product: InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: GE Healthcare sent an An Urgent Medical Device Correction letter dated November 26, 2013, to all affected customers. The letter identified the product, the problem, and provided instructions for immediate mitigation of the issue. No product is being returned. The affected systems in the field will be corrected. Customers with questions were instructed to contact the service team at 800-874-7378. For questions regarding this recall call 801-536-4952.
Quantity in commerce: 654
Distribution: Nationwide Distribution
Product codes and lots: Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0524-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0524-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-17

Product code LLZ

K960330Class IIInstatrakVisualization Technology, Inc. / cleared 1996-04-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)