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readonthegoapp
This seems to be one of those things that is just...completely par for the course in America.

Every couple of years there is a new blockbuster report, and then...nothing.

FDA bought off. Not a good situation.

s1artibartfast
Please keep in mind that this was a globally marketed device with approval in Europe. European health authorities weren't any more proactive in addressing the issues.

Ultimately, it was the manufacturer who stepped up and pulled the devices off the market.