Recall Z-1630-2023— Medtronic Navigation, Inc.
Class I · Ongoing
Class I FDA medical device recall by Medtronic Navigation, Inc., initiated 2023-04-11. It names one FDA 510(k) clearance: K221087. Product: StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems. Reason: 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 navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury.
- Recalling firm
- Medtronic Navigation, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-04-11
- Firm location
- Lafayette, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
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 navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury
Data sourced from openFDA. This site is unofficial and independent of the FDA.