This voluntary medical device correction is being taken following the investigation of six customer reports stating that a total of four ventilators became inoperable during use. One of these reports indicated that, following the ventilator becoming inoperable while providing mechanical ventilation, the patient experienced cardio-respiratory complication, and passed away three days later. The investigation identified the root cause for these reports to be a manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly. Only the affected serial numbers are impacted by this medical device correction. Recall start date: 2021-11-09
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