Reported Earlier, 'FDA Says Medtronic Navigation Inc. Recalls StealthStation S8 Application Version 2.0 And 2.0.1 In U.S. Due To A Software Glitch'
Portfolio Pulse from Benzinga Newsdesk
The FDA has announced a Class I recall of Medtronic's StealthStation S8 Application Versions 2.0 and 2.0.1 due to a software glitch that could cause surgical plan data to shift locations, potentially leading to serious injuries or death. No injuries or deaths have been reported. Medtronic has initiated corrective actions by sending an Urgent Medical Device Correction Letter to customers and will provide a software update.
December 19, 2023 | 5:49 pm
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Medtronic's StealthStation S8 Application Versions 2.0 and 2.0.1 have been recalled by the FDA due to a serious software issue. The company is actively addressing the problem, but the recall may affect investor confidence and the company's reputation in the short term.
Class I recalls are the most serious type of recalls and can have significant negative impacts on the company's stock price due to potential reputational damage and the costs associated with the recall. However, the absence of reported injuries or deaths may mitigate the impact slightly.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100