China NMPA Product Recall - Nellcor™ OxiMax® N-65 Handheld Pulse Oximeter, Nellcor™ OxiMax® N-560 Pulse Oximeter

Covidien Medical Devices International Trading (Shanghai) Co., Ltd., a subsidiary of the Medtronic Group, initiated a voluntary recall on May 25, 2015, for specific pulse oximeter models. The affected products, which include the Nellcor™ OxiMax® N-65 Handheld Pulse Oximeter and Nellcor™ OxiMax® N-560 Pulse Oximeter, presented a critical malfunction: their screens failed to display numbers completely. This defect could lead healthcare professionals to misinterpret vital patient data, specifically blood oxygen saturation and pulse rate, potentially compromising patient safety. The recall was conducted under the oversight of the National Medical Products Administration (NMPA) and applied globally, affecting 2090 units in China. As required actions, Covidien issued a Medical Device Safety Warning and notified all relevant customers via a formal letter. Customers were instructed to perform a Post-Activation Self-Test (POST) before each patient use to verify device functionality and were also required to complete and return a confirmation form to Covidien, ensuring acknowledgment of the safety measures.