Z-0812-05

ENTrak Navigation and Visualization System

Name: Z-0812-05 ENTrak Navigation and Visualization System
Creator: GE OEC Medical Systems,Inc
Published: 2004-07-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2004-07-12 / Terminated

FDA source

GE OEC Medical Systems,Inc began a recall of ENTrak Navigation and Visualization System on 2004-07-12. The reason FDA records is "Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0812-05
Status: Terminated
Initiated: 2004-07-12
Posted: 2005-05-11
Terminated: 2011-08-02
Recalling firm: GE Healthcare
Product: ENTrak Navigation and Visualization System
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
FDA root cause: Other
Action: Customers were notified by letter on 07/12/04.
Quantity in commerce: 2 kits
Distribution: Domestic distribution: VA, CT, KY, NJ, LA, PA, TN, OK, CA. Foreign distribution to Germany. There were no military or VA facilities.
Product codes and lots: Axcess System Kit P/N: 1005869-001

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)