Z-0688-05

ENTrak Plus Navigation and Visualization System

Name: Z-0688-05 ENTrak Plus Navigation and Visualization System
Creator: OEC Medical Systems, Inc
Published: 2004-12-13
License: https://open.fda.gov/license/

GE Healthcare / initiated 2004-12-13 / Terminated / root cause: sterility

FDA source

OEC Medical Systems, Inc began a recall of ENTrak Plus Navigation and Visualization System on 2004-12-13. The reason FDA records is "Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0688-05
Status: Terminated
Initiated: 2004-12-13
Posted: 2005-04-08
Terminated: 2011-07-08
Recalling firm: GE Healthcare
Product: ENTrak Plus Navigation and Visualization System
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
Root cause tag: sterility
FDA root cause: Other
Action: Customers were notified by letter on 12/13/04.
Quantity in commerce: 67 units
Distribution: Domestic distribution: Nationwide, including 4 military facilities and 4 VA facilities. Foreign distribution: Canada.
Product codes and lots: The particular accessories (''Sensors'') involved are: Short Range Transmitter (P/N 1004587 or 1002008); Snap Receiver Cable (P/N 1004069 or 1001989); Extended Range Transmitter (P/N 1004070 or 1003991); and T-Handle Spine Tool Receiver (P/N 1004072).

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)