2 ms·
Great! This is the graph for the Philips CPAP machines which had a big scandal associated with them and which likely got approved through various 510ks. https:
by oezi 3y ago
Great! This is the graph for the Philips CPAP machines which had a big scandal associated with them and which likely got approved through various 510ks.
https://www.nytimes.com/2023/09/07/health/cpap-defect-recall-philips-respironics.html https://www.nytimes.com/2023/09/07/health/cpap-defect-recall...
One nitpick about the way that 510k.fyi presents this. A 'recall' in FDA lingo doesn't mean that the manufacturer withdrew the device from the market. It just means that they informed customers that there is something wrong with the device which requires any kind of modification by the manufacturer. It is thus a little bit ambiguous to say that a device was recalled if all this might mean that there was some software update which had to be applied.
- wcedmisten 3y agoHi, author here! That's a good point, I should probably add a disclaimer about what recalls mean in this context. Unfortunately I couldn't find a good way to determine whether the recall might be a systemic design issue that would affect other similar devices or something that can be remediated for an individual product, like a labeling issue. I was also thinking of changing the color code based on the recall severity (class I, II, or III)