China NMPA Product Recall - Non-invasive hemodynamic detection system

Shenzhen Zehui Medical Technology Co., Ltd. has initiated a voluntary recall of its Non-invasive Hemodynamic Detection System. This action, published by the National Medical Products Administration (NMPA) on July 20, 2022, addresses non-compliance with technical requirements identified through customer feedback. The affected products include specific production batch numbers 20211220 and 20220530.

The primary issue prompting this recall is the product's failure to meet established technical specifications. While the document does not specify formal inspection dates leading to this finding, the root cause is attributed to customer feedback regarding the system's performance. The regulatory framework governing this action falls under the purview of the NMPA, which hosts the official recall notification.

As a required action, Shenzhen Zehui Medical Technology Co., Ltd. is voluntarily removing the non-compliant devices from the market. The specific recall level for this event was not detailed in the provided information. This recall underscores the company's responsibility to address product quality concerns and ensure device safety in accordance with medical device regulations overseen by the NMPA.