FDA Device recall Z-2707-2020
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locatin…
- FDA Device
- Class II
- terminated
- Published 2020-08-05
On 2020-08-05 the FDA classified a Class II recall of StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locatin… by Medtronic Navigation, citing there is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the activ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2707-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-05 |
| Published | 2020-08-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
Product
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.
Reason
There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or illnesses have been reported, If impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm.
Identifiers
| code_info | StealthStation S7 Serial Number N06164844 with Polaris Spectra Camera Serial Number P7-01896; and StealthStation S7 Ser…StealthStation S7 Serial Number N06164844 with Polaris Spectra Camera Serial Number P7-01896; and StealthStation S7 Serial Number N07308697 with Polaris Spectra Camera Serial Number P7-18852. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2707-2020%22
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