SQA Regulatory Surveillance Summary | Monthly Update 2022 – May
SQA
JULY 8, 2022
In March 2022, Philips Health Systems informed the MHRA of an important safety issue due to potential unexpected shutdowns of all their V60 and V60 Plus non-invasive ventilators. V60 and V60 Plus devices are designed for in-hospital use. 536/2014 on Clinical Trials, which will replace EU Annex 13.
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