China NMPA Product Recall - Rainbow DC Series Reusable Sensors

Masimo Corporation, through its Chinese subsidiary Masimo (Beijing) Medical Technology Co., Ltd., initiated a voluntary Level III recall of its Rainbow DC Series Reusable Sensors (Registration No. 20142215) in China. This action, reported on May 16, 2016, and publicized by the National Medical Products Administration (NMPA) on June 22, 2016, addresses critical product deficiencies.The primary issues stemmed from manufacturing inconsistencies, where certain sensor batches were produced in an incompatible configuration. This flaw could lead to either a complete failure in providing SpCO (carboxyhemoglobin) or SpMet (methemoglobin) readings, or the delivery of inaccurate data, depending on the device's firmware. Specifically, the recall noted that displayed SpCO measurements might be erroneously inflated across their range, and SpMet values exceeding 6% could exhibit an average negative bias of 1.5%.As a result of these significant performance compromises, Masimo's required action was to promptly inform affected customers to cease using the Rainbow DC Series Reusable Sensors and to facilitate the immediate return of the products. This recall impacted two units imported into China. The company's swift response, under the NMPA's regulatory oversight, aimed to mitigate potential patient safety risks associated with unreliable blood gas monitoring.