
Episode 121: Therac-25
Well There‘s Your Problem
00:00
The FDA Recall - I Can't Go Wrong.
The FDA issued a voluntary recall notice at this point. They basically sort of sent engineers out to go... This is the 80s. There's only 11 sites where this is installed. So you've got to do 11 times. And they audited the changes internally and end users were told they could resume use once necessary modifications have been made. The evidence for the belief that radiation burn could not be caused by a machine included a probabilistic risk assessment showing the safety had increased by five orders of magnitude as a result of the micro switch fix.
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