China NMPA Product Recall - Patient monitor

Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall of specific patient monitor models on October 11, 2017, as reported by the National Medical Products Administration (NMPA). The recall addresses a critical product issue where the patient monitors, registered under CFDA (Imported) 2014 No. 3214509, CFDA (Imported) 2014 No. 3214508, and CFDA 2012 No. 3214099, may automatically activate an ECG filtering function. This activation occurs when certain technical alarm messages are triggered, often due to mechanical damage or liquid ingress. The primary concern is that this automatic filtering can lead to inaccurate ST values in the 12-lead electrocardiogram (ECG) readings, potentially compromising patient diagnosis and care. This proactive measure by Philips (China) Investment Co., Ltd. aligns with medical device safety regulations overseen by the NMPA, ensuring the integrity and reliability of medical equipment in clinical settings. Detailed information on affected product batches and specifications is available in the "Medical Device Recall Event Report Form" associated with NMPA Index No. JGXX-2017-10939.