China NMPA Product Recall - Monitor defibrillator

Philips Medical Systems (Philips China) Investment Co., Ltd. reported a Class II voluntary recall of its monitored defibrillators (Registration Certificate No.: 20163214004) to China's National Medical Products Administration (NMPA) on October 9, 2017. The recall addresses a critical safety concern related to the EtCO2 monitoring function. Specifically, if the device fails to obtain an EtCO2 measurement, it displays a dashed line in the waveform and a question mark, indicating a malfunction. This issue presents several significant patient hazards, including the inability to identify crucial intubation or ventilation problems due to a lack of carbon dioxide plethysmogram display, impaired monitoring of CO2 and respiratory rates, and forcing medical personnel to rely on less direct parameters for adjusting ventilation. The affected product models are M3535A and M3536A. The recall primarily impacts units distributed in Canada, South Africa, and the USA. It is important to note that no affected batches of these monitored defibrillators were sold within China. Consequently, while Philips (China) formally reported this global recall event, direct corrective actions or product retrieval within the Chinese market are deemed "not applicable" given the absence of distributed affected products in the region. This voluntary action underscores Philips' commitment to product safety and regulatory transparency.