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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
by jt2190 3y ago
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/philips-north-america-llc-recalls-panorama-10t-hfo-due-risk-explosion-during-quench-procedure-caused https://www.fda.gov/medical-devices/medical-device-recalls/p...
- akira2501 3y agoThat'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.
- s1artibartfast 3y agoIt 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).
- pkaye 3y ago[flagged]
- s1artibartfast 3y agoI 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.
- tedunangst 3y agoIt's copy pasta from fight club.
- s1artibartfast 3y agoI get that, but it is also wrong.
- Jabbles 3y agoThere has been one reported event of an explosion in 22 years of use. There have been no reports of injury or death. I wonder what the total negative health consequences of not being able to use all those MRI machines until they are serviced will be.
- fnordpiglet 3y agoAlso doesn’t say it happened to a Phillips machine, my read is that’s for any MRI machine - ever. So, yeah, a recall, but nothing ominous about it. Things get recalled all the time.
- sverhagen 3y agoYet 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.
- deleted 3y ago[deleted]
- mcpackieh 3y agoThe 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.
- 3y ago