China NMPA Product Recall - Monitor defibrillator

Philips Medical Systems (Philips China) Investment Co., Ltd. initiated a voluntary Class II recall of its monitored defibrillators (models M3535A, M3536A), as reported by the National Medical Products Administration (NMPA) on November 3, 2017, based on a report dated October 9, 2017. The recall addresses a critical safety concern where the EtCO2 monitoring function may fail to obtain measurements. This issue poses a significant risk to patients by potentially hindering the identification of crucial intubation or ventilation problems, impeding the monitoring of CO2 and respiratory rates, and forcing medical personnel to rely on less precise parameters for ventilation adjustments, despite the device displaying a warning. The affected devices, registered under National Medical Device Registration Certificate 20163214004, are designed for various life-sustaining functions including defibrillation, cardioversion, pacing, and multi-parameter monitoring. Although classified as a Class II recall, the specific affected batches were not sold in China. Consequently, no corrective actions or affected units were reported for the Chinese market, as indicated by the 'Not Applicable' status for recall requirements and handling methods within China. The recall primarily impacts regions including Canada, South Africa, and the USA, where these units were distributed.