China NMPA Product Recall - Baby warming station

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its infant warmers, as updated on May 19, 2020, following an initial report on January 21, 2020. This action was prompted by a critical safety issue: when operated in manual mode without a temperature probe, the device's heater continues to function at the user-set power. Crucially, this operation occurs without triggering an alarm or automatically reducing the output power, posing a potential risk. The recall, overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, involves specific models, specifications, and batches of infant warmers (Registration Certificates CFDA (Imported) 2013 No. 3541372 and CFDA Import Registration No. 20163545180). GE Healthcare updated its initial recall report to reflect adjusted quantities of affected products imported and sold in China. The company is required to manage the recall process for these medical devices to address the identified safety concern.