China NMPA Product Recall - Patient monitor; patient monitor

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall for several models of its patient monitors. This action, reported on June 8, 2020, by the Shanghai Municipal Drug Administration under the oversight of the National Medical Products Administration (NMPA), addresses a significant safety concern.The core issue occurs when the Patient Data Module (PDM) is utilized with specific GE patient monitors (B450, B650, B850, Solar 8000M, Solar 8000i). If pacing detection is enabled on the monitor and an automated external defibrillator (AED) is subsequently used, the AED's low-frequency signal can cause the PDM to generate incorrect ECG information. This leads to the monitor displaying a false cardiac arrest and activating an alarm.This malfunction is critical as it could delay essential clinical evaluation and intervention for actual cardiac arrhythmias. The recall encompasses patient monitors identified by various CFDA Import Registration Numbers, including 20073211603, 20143212974, 20143212922, 20143212977, 20193072135, 20183072623, and 20183072625. Comprehensive details regarding the affected product models, specifications, and batches are provided in the associated "Medical Device Recall Event Report Form."