China NMPA Product Recall - Central Monitoring System (Version 2.66)

Shenzhen Mindray Medical International Limited initiated a voluntary recall of its Central Monitoring System (V2.66 software), as reported on August 23, 2021. The recall, announced under the oversight of the National Medical Products Administration (NMPA) and the Guangdong Provincial Drug Administration, stemmed from internal testing conducted by the company. During these tests, Mindray discovered that the Central Monitoring System, registered under Certificate No.: 粤械注准20152070444, failed to effectively display critical information under certain operational conditions.

This identified software anomaly has led to a Level III voluntary recall, signifying a situation where the use of, or exposure to, the affected product is not likely to cause adverse health consequences. Shenzhen Mindray Medical International Limited is responsible for executing this recall. Specific details regarding the affected product models, specifications, and batch numbers are referenced as being available in an accompanying "Event Report Form" and "Recall List" attachment. This proactive measure by the company highlights its commitment to addressing product performance and ensuring the reliability of its medical devices.