China NMPA Product Recall - Infant incubator

Likang Huayao Biotechnology (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its infant incubators on August 16, 2019, following a national supervision and spot check. The recall was prompted by the discovery that the incubators did not comply with section 49.2 of the GB 11243-2008 standard. Analysis and testing indicated that an intermittent malfunction of the product's memory chip was the likely cause of the non-compliance. While the company reported no related adverse event reports to date, the National Medical Products Administration (NMPA) document details the necessity of this action to address the identified product issue. The recall specifically targets infant incubators with Registration Certificate No.: 20153540700, with further details regarding specific models, specifications, and batches available in an attached Medical Device Recall Event Report Form. This action underscores the company's commitment to product safety and compliance with regulatory standards set by the NMPA.