Respironics California, LLC recalls Philips V60 Ventilators with Power Management PCBA part numb
Recalled Product
Philips V60 Ventilators with Power Management PCBA part number 1055906
Hazard / Issue
Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia
Issued by
FDA
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