China NMPA Product Recall - Cryo slicer

On October 26, 2020, Sakura Medical Technology (Taizhou) Co., Ltd. initiated a voluntary Class II recall of 109 cryostat slicers across various models (POLAR-D-JC, POLAR-DM-JC, POLAR-D, POLAR-DM) in China. This action was mandated by the product manufacturer, Sakura Seiki Co., Ltd., and reported to the National Medical Products Administration (NMPA) and the Jiangsu Provincial Drug Administration. The recall stems from a critical software defect. When a fault alarm occurs during the ozone treatment cycle of the cryostat, the device’s window could inadvertently unlock after the alarm is canceled. This issue poses a potential safety risk to users. To rectify the problem and ensure patient and user safety, Sakura Medical Technology (Taizhou) Co., Ltd. deployed engineers to affected sites. Their corrective measures included upgrading the device software, installing a protective cover over the window lock's forced release mechanism, and distributing updated instruction manuals to all customers. Affected customers were also notified directly through official letters outlining the required actions and solutions. This recall demonstrates the company's commitment to adhering to medical device safety standards under NMPA regulations.