China NMPA Product Recall - Pulse oxygen gaussometer

MASIMO CORPORATION, through its subsidiary MASIMO (Beijing) Medical Technology Co., Ltd., initiated a voluntary Class III recall of its Radical-7 touchscreen pulse carboxyoximeters in China. The National Medical Products Administration (NMPA) published this recall notice on October 10, 2017, following a report submitted by the company on September 30, 2017.The core issue stemmed from the sale of certain touchscreen Radical-7 devices in China under a registration certificate originally intended for an older, non-touchscreen version of the Radical-7. Although a new, appropriate registration certificate for the touchscreen model was later obtained, the misrepresentation of the product's certification required corrective action. This recall primarily addresses a regulatory compliance issue rather than a defect in the device's safety or performance.As part of the recall, customers are instructed to return affected touchscreen Radical-7 devices. MASIMO is committed to replacing these units with devices accompanied by the correct and valid registration certificate. The company's required actions involve collaborating with distributors to identify and notify affected customers, facilitating product replacements, conducting multiple follow-ups with distributors, and submitting weekly progress reports to the Beijing Municipal Drug Administration. A final recall report will be submitted upon completion of these actions.