submitted 2 years ago* (last edited 2 years ago) by [M] to c/softwaregore@lemmy.world
 

Reminds me of the Therac-25 incident..

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[–] 9 points 2 years ago (1 child)

FDA requirements were the first thing that popped into my mind. Is it possible somehow these devices fall under different regulations than "medical devices"? I am only vaguely familiar with the applicable 21 CFR regs. This seems like a pretty gargantuan screw up since it could, I would think, kill people.

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