China NMPA Product Recall - Ventilator

Datex-Ohmeda, Inc., the manufacturer, has initiated a voluntary Class II recall of specific ventilator models and batches. This recall, reported by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. on September 17, 2020, addresses a potential issue with the oxygen sensor within these devices. The primary concern is that the oxygen sensor defect may lead to the displayed fractional inspired oxygen (FiO2) value not accurately reflecting the actual oxygen delivery rate. Such inaccuracies could have serious implications for patient care, making this a critical safety concern. The National Medical Products Administration (NMPA) of China published this recall information on September 18, 2020, confirming the regulatory oversight of this event. The required action by the company is to conduct a full recall of the affected ventilators to mitigate potential risks associated with inaccurate oxygen readings. Further details regarding the specific models, specifications, and batches involved are contained in the attached 'Medical Device Recall Event Report Form'.