China NMPA Product Recall - Medical infrared forehead thermometer

Shenzhen Qianxi Electronics Technology Co., Ltd. initiated a voluntary Level III recall of its medical infrared forehead thermometers, as reported to the Guangdong Provincial Drug Administration on May 19, 2022. The company, operating under the regulatory oversight implied by the National Medical Products Administration (NMPA) framework in China for medical devices, proactively took this action. The core issue driving this recall is the identified need to remove specific batches of these thermometers from the market. While the provided document does not detail specific inspection dates or the exact nature of any violations or deficiencies that precipitated the recall, it confirms the company's commitment to addressing product concerns through self-initiated corrective measures. The required action involves the systematic recall of affected product models, specifications, and batches, with comprehensive details documented in an attached "B Event Report Form" that was not included in this excerpt. This voluntary recall underscores the company's responsibility in maintaining product quality and safety within the stringent medical device regulatory environment.