FDA Device recall Z-1985-2012
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus
- FDA Device
- Class I
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class I recall of InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus by Ge Oec Medical Systems, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1985-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2006-09-15 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Oec Medical Systems |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | IT35050P, IT35071, IT35129, IT35133, IT35134, IT35139, IT35140, IT35143P-RC, IT35144P, IT35145P-RC, IT35146, IT35147P-R…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, IT35364 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1985-2012%22
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