China NMPA Product Recall - Lung function instrument

Beijing Maibang Optoelectronic Instrument Co., Ltd. initiated a voluntary Class III recall of its Lung Function Instruments (model MSA99, registration number 京械注准20182210193) following an internal self-inspection. The recall, publicly announced by the National Medical Products Administration (NMPA) on July 8, 2019, stemmed from the finding that the updated product registration certificate number had not been timely applied to the back labels of the devices. A total of 82 affected units, intended for measuring vital capacity, forced vital capacity, and maximum minute ventilation in hospitals, were distributed within China. This action falls under the NMPA's regulatory framework for medical device oversight, requiring manufacturers to ensure accurate and up-to-date product labeling. To rectify the issue, Beijing Maibang Optoelectronic Instrument Co., Ltd. committed to two main corrective actions. First, they will reproduce the product back labels to incorporate the correct, new registration certificate details. Second, the company will directly inform all affected customers about the recall and facilitate the update of the back labels on the instruments already in circulation, ensuring compliance with current regulatory standards.