Drug recall
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7…
FDA recall event 92141 · Class I · Medtronic Navigation, Inc.
Key facts
| Event ID | 92141 |
|---|---|
| Recall numbers | Z-1630-2023 |
| Recalling firm | Medtronic Navigation, Inc. |
| Product type | Devices |
| Products | StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other… |
| Initiation date | Apr 11, 2023 |
| Report date | Jun 14, 2023 |
| City | Lafayette |
| 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: