November 9, 2023

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FDA Recall: Software Anomaly Could Result in Unintended Location of Planning Data

November 9, 2023Allison PateNews

Company: Medtronic Navigation, Inc. Date of Enforcement Report: 11/09/2023 Class I PRODUCT StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as...

FDA Recall: Software Anomaly Could Result in Unintended Location of Planning Data

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FDA Recall: Software Anomaly Could Result in Unintended Location of Planning Data

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