The Food and Drug Administration’s web page about the recall is clearly written:
(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...
(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...
I wonder what the total negative health consequences of not being able to use all those MRI machines until they are serviced will be.
So, yeah, a recall, but nothing ominous about it. Things get recalled all the time.
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.
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.
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).