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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, a
by akira2501 3y ago
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.
- 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.