In a recent announcement, Medtronic plc has initiated a voluntary recall of certain Newport™ HT70 and HT70 Plus ventilators, along with specific Newport™ service parts, following an investigation into customer complaints. The U.S. Food and Drug Administration (FDA) has classified this action as a Class I recall, indicating a potential risk of serious adverse health consequences. The issue stems from two separate capacitors on one of the ventilator's controller Printed Circuit Board Assembly (PCBA), which could lead to the ventilator shutting down during use or the shutdown alert alarm failing to sound effectively. Medtronic advises discontinuing the clinical use of the affected devices and recommends that customers replace them with alternative ventilation means. The company continues to work with the FDA and global regulatory bodies to address the situation. For further queries, Medtronic has provided contact details for customer service and technical support.
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