FrameLink — Class II medical device recall Z-2314-2016
Terminated recall by Medtronic Navigation, Inc., reported 2016-08-10, distributed nationwide. Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Soft
| Recall number | Z-2314-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2016-07-18 |
| Classified | 2016-08-02 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2016-12-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, IN |
| Quantity | 27 in |
| Reason classes | software |
| Model numbers | 9733986-02 |
Product
FrameLink. 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 for recall
Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2314-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.