China NMPA Product Recall - V60 ventilator

Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its V60 ventilators, as reported by the National Medical Products Administration (NMPA) on April 10, 2020. The recall stems from a critical manufacturing defect involving a solder joint (R31) on the first-generation power management printed circuit board. This defect can lead to premature failure of the ventilator. The primary issue is the potential for the turbine to lose power and decelerate, triggering a high-priority "Check Ventilator" visual and audible alarm. Clinicians are advised to immediately transfer patients to a standby ventilator in such events. A more severe, albeit rare, scenario involves a complete disconnection failure mode, which can cause the ventilator to shut down unexpectedly without any alarm. The company's action falls under NMPA's regulatory oversight for medical devices. Further details regarding the specific models, specifications, and batches affected are available in the accompanying "Medical Device Recall Event Report Form".