Z-2136-2012Class I

Radiological Image Processing System The system is an aid to locate anatomical structures during open or...

Name: Z-2136-2012 Radiological Image Processing System The system is an aid to locate anatomical structures during open or...
Creator: GE OEC Medical Systems, Inc
Published: 2007-04-02
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-04-02 / Terminated / root cause: software

FDA source

GE OEC Medical Systems, Inc began a recall of Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for... on 2007-04-02. FDA classified it as Class I and gives the reason as "The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image". 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-2136-2012
Classification: Class I
Status: Terminated
Initiated: 2007-04-02
Posted: 2012-08-08
Terminated: 2012-09-28
Recalling firm: GE Healthcare
Product: Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CS, MR, or X-ray.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare sent an Urgent Recall Notice dated April 2, 2007, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were asked to call 800-874-7378. For questions regarding this recall call 801-536-4952,
Quantity in commerce: 17
Distribution: Worldwide Distribution - USA including MO, IL, LA, FL, NH, TX, IN, PA, NJ and the countries of France and China
Product codes and lots: E9-0002-G, ES-0013-G, E9-0036-G, E9-0040-G, E9-0041-G, ES-0014-G, ES-0016-G, ES-0033-G, ES-0043-G, ES-0041-G, ES-0042-G, ES-OO84-G, ES-0086-G, ES-0163-G, E9-0089-G, ES-0026-G, ES-0044-G

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2136-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2136-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-08

Product code LLZ

K994270Class IIInstatrak 3000 System with Fluorotrak Module, Model It3000Visualization Technology, Inc. / cleared 2000-03-09

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)