China NMPA Product Recall - Ventilator

Air Liquide Medical Systems S.A., through Air Liquide Medical Supplies (Beijing) Co., Ltd., initiated a voluntary Class II recall of specific ventilators on July 10, 2017, under the oversight of the National Medical Products Administration (NMPA). This action addresses two critical issues. Firstly, a manufacturing defect in the power boards of ventilators with serial numbers prior to MT50-4540 was identified. This defect could cause an unexpected loss of 5V voltage, leading to a sudden shutdown of the machine during operation. Secondly, the manufacturer discovered that overseas home users were improperly utilizing the built-in battery, which could result in a sharp decrease in effective battery charge and an abrupt automatic shutdown when the device relied solely on its internal power source. To mitigate potential risks to patients, Air Liquide Medical Systems S.A. is recalling the affected ventilators, identified by Registration Certificate No.: CFDA (Imported) 2014 No. 3540539. A Class II recall signifies that the product's deficiencies may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Further details on specific models and batches are available in the accompanying Medical Device Recall Form.