The bar for recall is actually relatively low. Basically, when you find a fault (somehow, maybe in regular QC in manufacturing, or something bad actually happens in the field, or some engineer is fucking around), the question is &quot;can this affect patient safety&#x2F;outcome in the field&quot;. If the answer is at all not a certain &quot;no&quot;, then you&#x27;re probably thinking recall at that point, unless you can adequately root cause and contain it.<p>Since the nature of &quot;oh oops&quot; is that they tend to affect systems in ways that are not anticipated, there&#x27;s often insufficient evidence to rule out danger to patients, and therefore there&#x27;s a recall.<p>For example, if you sold 10,000 diagnostics machines, and then discovered that because of stack up of tolerances in electrical components, something like 1 in 100,000 machines will have a fault that affects the customer safety. However, because your original analysis (during design phase) did not show this problem, you never bothered recording the actual performance characteristics of 40% of the components involved in the stack up.<p>Now you&#x27;re in a pretty awkward situation, that could result in a recall. And it could very well by that all 100,000 machines sold are just fine.