US FDA issues Class I recall on Medtronic's Stealthstation S8 cranial surgery system due to software error causing missing digits in display.
The US FDA has issued a Class I recall on Medtronic's Stealthstation S8 cranial surgery system due to a software error. The recall involves 876 systems distributed between 2017-2024 and affects versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1. The issue, reported by 28 customers, causes missing digits in the display, potentially leading to incorrect measurements for biopsy tip stop placement during surgery. Medtronic plans to release a software update to resolve the problem without charge.
June 05, 2024
5 Articles