I imagine such devices have firmware that can't be easily updated. Bummer to throw away hardware unless it's a hardware bug.
Surprising, though. I imagine the software integration for such a device should be quite strict, I wonder what actually happened (a missed code review, faulty logic, etc.).
https://www.fda.gov/news-events/press-announcements/fda-clea...
FDA's information about the recall:
https://www.fda.gov/medical-devices/medical-device-recalls-a...
gnabgib•2mo ago