StealthStation" S7 System with Polaris Spectra Camera part number PSU… — Class II medical device recall Z-2707-2020
Terminated recall by Medtronic Navigation, Inc., reported 2020-08-05, distributed nationwide. There is a potential for specific camera units to be affected by a characterization issue during manufacturing
| Recall number | Z-2707-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2020-06-05 |
| Classified | 2020-07-27 |
| Reported by FDA | 2020-08-05 |
| Terminated | 2024-05-28 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| Serial numbers | N06164844, N07308697, P7-01896, P7-18852 |
| Model numbers | 9733437 |
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 for recall
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.
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-2707-2020. 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.