Poor Wire Insulation Prompts Infant Ventilators Recall
Salt Lake City-based Bunnell performed a voluntary Class I recall of Life Pulse high-frequency ventilator patient circuits distributed between March and October 2012. The circuits are used to treat infants with respiratory distress syndrome complicated by pulmonary air leaks who are failing on conventional ventilation. Some of the wire insulation in the recalled units may melt, producing sparks and smoke near the humidifier cartridge. The defect can cause serious adverse events, including death. The recall notice instructs Bunnell customers on steps to take if they feel the circuits are medically necessary.
From hardware to software, anything can cause the FDA to issue a recall. With emerging software applications, how safe is your company’s device?
A recent FDA report found 25 percent of all device recalls were the result of bad software.
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