Earlier quoted context omitted.
Do you know absolutely every medical device in existence and do you know how broad the definition of a medical device is (including e.g. the monitor attached to the PC used for displaying X-ray images)?
I worked in medical device quality control and so, yes, I know all about the FDA requirements for medical devices and ISO 13485. I can say, with certainty, that base Linux would not be allowed to run in a medical device in the USA. It's software of unknown provenance (SOUP) and would absolutely NOT be used as-is.
Felt kinda bad until I thought about how well a "Linux literally killed me" headline would do on HN, but then I realized I wouldn't be able to post the article if I actually died. Such is life. Or death? One or the other.