FDA Issues Class I Recall on Cranial Surgery System Due to Software Error

Published on June 5, 2024

The U.S. Food and Drug Administration (FDA) has announced a Class I recall on Medtronic’s Stealthstation S8, a cranial surgery system, for a software error on Wednesday. Class I recall is the most serious type of recall, use of these devices may cause serious injuries or death, according to the FDA. Stealthstation S8 is a cranial surgery system that aids in locating anatomical structures during neurosurgery. The recall is made on Stealthstation S8 versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1, affecting 876 systems, which were distributed between March 21, 2017 and March 22, 2024. Medtronic, the Colorado-based medical device company, issued the recall on April 10 after customers complained that it was causing incorrect measurements and placements of a biopsy tip stop during surgical navigation....

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