Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1630-2023 — StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

U.S. FDA — Device Enforcement · United States · 2023-04-11 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1630-2023
Date of alert
2023-04-11
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Medtronic Navigation, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00763000631635
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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