China NMPA Product Recall - Pulse oxygen gaussometer

MASIMO CORPORATION initiated a voluntary Class III recall in China for its Radical-7 touchscreen pulse carboxyometers, as reported by the National Medical Products Administration (NMPA) on October 10, 2017, based on a company report dated September 30, 2017. The recall stems from a regulatory compliance issue where certain touchscreen Radical-7 devices were initially sold in China under a registration certificate intended for an older, non-touchscreen version. Subsequently, MASIMO obtained a new, correct registration certificate for the touchscreen model, rendering the previously sold devices miscertified. This recall is not linked to product safety but addresses an administrative discrepancy concerning the device's regulatory approval status at the time of sale. MASIMO (Beijing) Medical Technology Co., Ltd. is requesting customers to return these miscertified Radical-7 units. The company commits to replacing all recalled devices with new ones that possess the appropriate and updated registration certificate. Corrective actions involve notifying distributors, providing product lists, ensuring customer notification and replacement, and conducting follow-ups with distributors. MASIMO is also required to submit weekly progress reports to the Beijing Municipal Drug Administration and a final recall report upon completion.