The software was not routing information about certain high-risk electrocardiogram events to cardiology technicians as intended. The issue, which lasted from July 2022 to July 2024, included failure to route information about suspected cases of atrial fibrillation or pause, supraventricular tachycardia, ventricular tachycardia and second- or third-degree atrioventricular block.
On Dec. 18, Philips and its subsidiary, Braemar Manufacturing, sent all affected customers an urgent medical device correction and information about which patients may need their data reprocessed.
This is a Class I recall, the FDA’s most serious classification, but does not involve removing devices from where they are used or sold.
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