China NMPA Product Recall - Pulse oximeter

The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Masimo Corporation for its Oximeter (National Medical Device Registration Certificate No. 20232070128). Reported on April 17, 2024, by Masimo (Shanghai) Industrial Co., Ltd., the core issue is a device malfunction where the power switch can turn on and off autonomously, without manual input. This critical defect presents a potential safety concern for users relying on consistent and accurate pulse oximetry readings.

Under the NMPA's regulatory framework, manufacturers are responsible for product safety and performance. The Class II designation for this recall signifies that the product defect could lead to temporary or medically reversible adverse health consequences, or that the probability of serious consequences is remote. Masimo Corporation’s required action involves executing a comprehensive voluntary recall to address the faulty Oximeter and mitigate associated risks. Further details regarding affected product models, specifications, and batch numbers are documented in the official "Medical Device Recall Event Report Form." This proactive measure ensures compliance with NMPA standards and prioritizes patient safety by removing non-conforming devices from circulation.