Yet the press this is getting is, like the article said, a black mark on Philips. They were a very diverse company, until they chose a few specific markets in which not to divest, healthcare being one of them. This must be quite the chill at headquarters.
The fact that nobody was injured in the previous incident is fortunate for anybody who might have been injured then, but doesn't diminish the importance of addressing whatever flaw caused the explosion. Considering that we're talking about a lot of liquid helium being improperly vented, the next time something goes wrong it could end up asphyxiating a hundred people.
Just because nobody was in the danger zone the first time it exploded doesn't mean you should count on nobody being in the danger zone the second or third time it might explode. This is the reason work site safety officers yell at people to report all near-miss incidents, not only the accidents that get people hurt. If something went wrong and nobody got hurt by chance coincidence, it might happen again when people are actually near it. Therefore a near miss incident needs to be addressed with the same seriousness as an accident that actually caused injury.
Even if it doesn't suffocate you, helium leaks can be pretty bad since they'll temporarily brick any modern phone with a MEMS oscillator (like a quartz time crystal, but smaller) in it. Not great if you need assistance.
That's absolutely a recall. An FDA recall means the product is in violation of the law. Those violations must be corrected or the device must be destroyed, and if not, then the FDA has the right to seize it.
The recall strategy in this case is not to ship it back to the manufacturer, but to have the manufacturer come out and service the device until it is again compliant with the law.
It has very little to do with the violations of the law. There is no law that states mri machines must have <X% chance of exploding.
The way these things work is that the firm has decided based on their data and reports to issue a recall and notify the FDA. The manufacturer recommends hospitals not use the device, however there is the possibility that they continue to do so (the probably won't for liability reasons).
I do medical risk assessments professionally and this is not at all how it works at all.
Most FDA approved medical products have inherent risk, e.g. X% of people will die.
The question is actually about how the actual performance aligns with disclosed and approved risks.
If Y% of people are hurt, the expectation was X%, and Y>X, then this is grounds for a penitential investigation and potential recall.
If it actually worked the way you stated, these machines would probably never have been recalled.
(edit: actually not a recall but a requirement that the machines are not used until they’re serviced)
https://www.fda.gov/medical-devices/medical-device-recalls/p...