China NMPA Product Recall - Temperature and pulse oximeter

Shenzhen Midea Medical Electronics Co., Ltd. has initiated a voluntary recall of its temperature and pulse oximeters, specifically batch number LA20201120009. This action, published on August 15, 2022, stems from a significant issue identified in the instruction manual accompanying these devices. The manual contains incomplete information regarding the indicator and function of signal incompleteness. This deficiency poses a substantial risk, as users may not fully comprehend the product's operation and signals, potentially leading to incorrect usage or misinterpretation of health data.

The recall is a proactive measure by Shenzhen Midea Medical Electronics Co., Ltd. to address this potential safety concern. While specific inspection dates are not detailed in the document, the company's decision highlights its commitment to product safety and user understanding. The regulatory oversight for this recall falls under the National Medical Products Administration (NMPA), with the information originating from the Guangdong Provincial Drug Administration. As a required action, Shenzhen Midea Medical Electronics Co., Ltd. is undertaking this voluntary recall to mitigate the identified risk.