Z-1985-2012Class I

InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus

Name: Z-1985-2012 InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus
Creator: GE OEC Medical Systems, Inc
Published: 2006-09-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-09-15 / Terminated / root cause: software

FDA source

GE OEC Medical Systems, Inc began a recall of InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to... on 2006-09-15. FDA classified it as Class I and gives the reason as "Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak...". 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-1985-2012
Classification: Class I
Status: Terminated
Initiated: 2006-09-15
Posted: 2012-07-12
Terminated: 2012-08-21
Recalling firm: GE Healthcare
Product: InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: 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 CT, MR, or X-ray.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak 3500 Plus System with Software version 5.2, the surgical Navigation and Visualization Application due to software related issues.
Root cause tag: software
FDA root cause: Software design
Action: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC sent an Urgent Safety Advisory Notice dated October 11, 2006 to all affected customers. The notice identified the affected product, problem and actions to be taken. Customers were informed that a GEHC OEC would be contacting their facility to verify the current software version installed at their site. If the issue affects their facility a software upgradewill be provided at no cost. Customers were advised to excercise caution when using the affected product until the 5.2.1software upgrade is completed. For question contact GE Healthcare Customer Service at 1-800-874-7378, option 1 or 1-801-536-4688, option 1. For questions regarding this recall call 801-536-4516.
Quantity in commerce: 86 units
Distribution: Worldwide Distribution - US (nationwide)
Product codes and lots: IT35050P, IT35071, IT35129, IT35133, IT35134, IT35139, IT35140, IT35143P-RC, IT35144P, IT35145P-RC, IT35146, IT35147P-RC, IT35148, IT35150, IT35153P, IT35156, IT35161, IT35162P-RC, IT35164, IT35169P-RC, IT35170G-RC, IT35175, IT35182G-RC, IT35183P-RC, IT35186P, IT35187P, IT35189P, IT35192P, IT35193P, IT35194P, IT35195P, IT35200P, IT35201P, IT35207P, IT35208P, IT35209P, IT35211P-RC, IT35214P, IT35215P, IT35220P, IT35222P, IT35223P, IT35225P, IT35228P, IT35231P, IT35232P, IT35234P, IT35236P, IT35237P, IT35240P, IT35242P, IT35245P, IT35248P, IT35251P, IT35252P, IT35253P, IT35263P, IT35265P, IT35269P, IT35270P, IT35271P, IT35273P, IT35274P, IT35277P, IT35280P, IT35284P, IT35285P, IT35290P, IT35293P, IT35294P, IT35295P, IT35296G, IT35297P, IT35299P, IT35300P, IT35302P, IT35303P, IT35304P, IT35309G, IT35310P, IT35311P, IT35312P, IT35315P, IT35316P, IT35322P, IT35323P, IT35324P, IT35330P, IT35331P, IT35334P, IT35341G, IT35342G, IT35344, IT35348P, IT35350P, IT35351P, IT35352P, IT35360P, IT35364P-RC, IT35365P, IT35367P, IT35372P, IT35377P, IT35380P, IT35383P.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1985-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1985-2012	Class I	Terminated	FDA Mandated	2012-07-18	2012-07-12

Product code LLZ

K040050Class IIInstatrak System with Multiple Dataset Navigation, Model It3500Ge Medical Systems Navigation and Visualization IN / cleared 2004-03-24

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)