FDA Device recall Z-0524-2014
InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA)
- FDA Device
- Class II
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class II recall of InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) by Ge Oec Medical Systems, citing GE OEC Medical Systems Inc is recalling InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0524-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-26 |
| Published | 2013-12-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Oec Medical Systems |
| Distribution | US |
Product
InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
Reason
GE OEC Medical Systems Inc is recalling InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.
Identifiers
| code_info | Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus |
|---|
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-0524-2014%22
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