Company: Medtronic Navigation, Inc.
Date of Enforcement Report: 06/02/2023
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
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
Medtronic Navigation, Inc.
VOLUME OF PRODUCT IN COMMERCE:
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