Two Recalls Released by NMPA
On October 26, 2020, two overseas manufacturers voluntarily recalled two different medical devices. The recalls are Class II and III Recalls. Detailed information about the manufacturers and recalled products are listed in the table below. Since China NMPA enhances the post-market surveillance, Bradynuoen can lead manufacturers in compliance with China regulations.
Manufacturer | Product Name | Recall Classification | Recall Reason | Link |
Sakura Seiki Co., Ltd
|
Freezing Microtome | Class II | Software defect | https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/ylqxzhhdf/20201027020148839.html |
Philips Medical Systems | MobileDiagnost wDR | Class III | Class II Chinese laser label is not attached | https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/ylqxzhhdf/20201027020146996.html |