China NMPA Product Recall - Arm-type electronic blood pressure monitor

Shenzhen Zhengkang Technology Co., Ltd. initiated a voluntary Level III recall for its Arm-Type Electronic Blood Pressure Monitors, model ZK-B869 (batch J20180311), reported around October 30, 2018. This action was taken after testing revealed that the product's instruction manuals did not meet required standards. The primary issue was the non-compliance of the instruction manuals with specific clauses, 4.2.3d) in YY0670-2008 and 4.12.3 of the registered product standard, which govern content requirements for non-invasive automatic blood pressure monitors. Approximately 5,000 units were affected, with 4,990 sold in China. The regulatory framework for this recall is under the National Medical Products Administration (NMPA) of China, guided by the "Regulations on the Management of Instructions and Labels for Medical Devices." Required actions include immediately reprinting and distributing compliant instruction manuals to customers, recalling and destroying all original non-compliant manuals, reviewing inventory to isolate and destroy any remaining non-compliant manuals for unsold units, and providing comprehensive training to engineering personnel on relevant regulatory clauses.