China NMPA Product Recall - Electronic thermometer

Aiola Medical Devices (Shenzhen) Co., Ltd. initiated a voluntary Class III recall for specific batches of its electronic thermometers. Published by the National Medical Products Administration (NMPA) on February 6, 2021, this action addresses a quality deviation discovered by the company. The core issue involved the electronic thermometers' automatic shutdown function, which was found to exceed the specified range of 8±1 minutes by approximately 20 seconds. This discrepancy from the established product specifications led the company to proactively recall the affected medical devices. Operating under the regulatory framework of the NMPA, the recall pertains to electronic thermometers registered under Certificate No. "粤械注准20172201466". Although no specific inspection dates were provided, the recall was voluntarily initiated by Aiola Medical Devices upon identifying the non-conformance. The company is now responsible for managing the recall process for the identified models, specifications, and batches, with further particulars expected to be detailed in a "Medical Device Recall Event Report Form." This action underscores the company's commitment to ensuring product safety and compliance within the NMPA's stringent medical device regulations.