Philips DreamStation, a robot to help you breath at night, turned out to be a killing machine.
Since April 2021, the FDA has received more than 116,000 MDRs [Medical Device Reports], including 561 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown.
Problems Reported with Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines
Manufacturers […] are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
ibid.
Philips recalled the machines and stop selling them in the US. Where else are those still on sale?
/ht @boingboing