China NMPA Product Recall - Medical jet cushion

Shanghai Sanhe Medical Device Co., Ltd. initiated a voluntary Class III recall for its medical air-jet cushions, as reported by the National Medical Products Administration (NMPA) on March 5, 2021, and by the Shanghai Municipal Drug Administration on April 1, 2021. The core issue driving this recall is the internal power connection wiring detachment, which occurred due to strong physical impacts during product transportation. This defect results in a poor fuse connection, rendering affected devices unable to power on and posing an operational reliability concern. The company proactively reported this malfunction for products associated with Registration Certificate No.: 沪械注准20172560596. This voluntary action adheres to the regulatory framework overseen by the NMPA, which mandates manufacturers address quality control deficiencies to ensure patient safety. A Class III recall signifies that exposure to the affected product is unlikely to cause adverse health consequences. Comprehensive details regarding the specific models, specifications, and batch numbers impacted by this recall are provided in the official "Medical Device Recall Report Form," guiding all relevant parties on appropriate follow-up actions.