Drug recall
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as…
FDA recall event 85901 · Class II · Medtronic Navigation, Inc.
Key facts
| Event ID | 85901 |
|---|---|
| Recall numbers | Z-2707-2020 |
| Recalling firm | Medtronic Navigation, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 5, 2020 |
| Report date | Aug 5, 2020 |
| Termination date | May 28, 2024 |
| City | Louisville |
| State | CO |
| Country | United States |
| FEI number | 1000517638 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: