China NMPA Product Recall - Pulse oxygen gaussometer

MASIMO CORPORATION, through its subsidiary MASIMO (Beijing) Medical Technology Co., Ltd., initiated a voluntary Class III medical device recall of its Pulse CarboxyOximeters. The recall, reported on September 30, 2017, and published by the National Medical Products Administration (NMPA) on October 10, 2017, stemmed from an administrative non-compliance rather than a product defect.

The core issue involved specific touchscreen Radical-7 devices sold in China utilizing a registration certificate initially designated for a previous, non-touchscreen version of the Radical-7. MASIMO had obtained a new, appropriate registration certificate for the touchscreen model; however, devices were distributed with the outdated certification.

Under NMPA regulations, MASIMO is implementing a structured recall. Required actions include customers returning affected touchscreen Radical-7 devices, which will be exchanged for products bearing the correct registration. The company must also notify distributors, supply lists of recalled serial numbers, ensure distributors inform and facilitate replacements for affected customers, and conduct follow-ups. MASIMO is mandated to provide weekly progress reports to the Beijing Municipal Drug Administration and submit a final recall report upon completion, ensuring compliance with medical device registration requirements.