Geoff,
These Monitors have gone through FDA process since they are also in the US market.
Furthermore anyone can access the FDA website and send a complaint. Such issues should be reported so that we as users are aware of it and able to put pressure on manufacturers to resolve these issues.
We should have global recalls on medical devices. Here is some news that FDA announced recently.
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UCM235964.pdf>
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310505Thanks
Tim
