China NMPA Product Recall - Rainbow DC Series Reusable Sensors

On May 16, 2016, Masimo Corporation initiated a voluntary Level III recall of certain batches of its Rainbow DC Series Reusable Sensors, as reported to the National Medical Products Administration (NMPA). The recall, handled in China by Masimo (Beijing) Medical Technology Co., Ltd., addresses significant manufacturing issues. It was discovered that some sensors were produced with an incompatible configuration, leading to potential failures in providing accurate readings for parameters such as SpCO (carboxyhemoglobin saturation) and SpMet (methemoglobin saturation), or delivering entirely inaccurate measurements. Specifically, SpCO measurements might be incorrectly elevated, and SpMet readings could show a negative bias, potentially exceeding 6%. In response, Masimo Corporation mandated immediate notification to customers to cease using the affected products and initiated the comprehensive recall of the identified sensor batches to mitigate any patient safety or diagnostic accuracy concerns.