A class 2 recall is defined as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Intuitive said the vibration only occurs in “extremely rare” situations and didn’t specify risks the mechanical vibration poses for patients.
Read the FDA’s recall notice here.
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Red Cross blood supply cut in half amid ‘staggering’ donor decline
Accuracy, access to at-home COVID-19 tests called into question
Medtronic heart pump recalled again after link to 4 patient deaths
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