FDA Device recall Z-2317-2016
Fusion ENT Application
- FDA Device
- Class II
- terminated
- Published 2016-08-10
On 2016-08-10 the FDA classified a Class II recall of Fusion ENT Application by Medtronic Navigation, citing medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2317-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-18 |
| Published | 2016-08-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
Product
Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Reason
Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Identifiers
| code_info | Model Number 9733467. All lot numbers manufactured by Medtronic Navigation are affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2317-2016%22
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