China NMPA Product Recall - Rainbow DC Series Reusable Sensors

Masimo Corporation, through its Masimo (Beijing) Medical Technology Co., Ltd. subsidiary, initiated a voluntary Class III recall of its Rainbow DC Series Reusable Sensors. This action was publicly announced by the National Medical Products Administration (NMPA) on June 22, 2016. The recall stems from manufacturing irregularities where specific batches of sensors were produced with incompatible configurations. These manufacturing flaws could result in significant performance issues, including the complete failure to provide SpCO (carboxyhemoglobin) readings or the delivery of inaccurate and potentially inflated measurements across the full range. The exact behavior of the affected sensors is dependent on the firmware version of the device’s technical board. Furthermore, Masimo identified that other elements, such as white matter content exceeding six percent, could contribute to an average negative bias of 1.5 percent. The company's proactive recall under the NMPA framework highlights its dedication to product safety and regulatory compliance, with detailed information about affected products available in the official "Medical Device Recall Event Report Form."