China NMPA Product Recall - Digital imaging plate scanner; intraoral imaging plate scanner

KaVo Shengbang (Shanghai) Dental Medical Devices Co., Ltd., acting on behalf of its manufacturer Palodex Group OY, initiated a voluntary Level III recall of power adapters for specific digital and intraoral imaging plate scanners. The recall was publicly announced by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on February 21, 2020. The core issue identified was the aging of the plastic insulation material within the power adapters of certain imaging devices manufactured in 2012 and 2013. This material degradation could potentially lead to device malfunction. The affected products include digital imaging plate scanners (CFDA Imported Medical Device Registration No. 20132311500) and intraoral imaging plate scanners (CFDA Imported Medical Device Registration No. 20132315524). The company is required to retrieve the specified power adapters from the market to mitigate any potential risks associated with the aging insulation, ensuring product safety and compliance with regulatory standards. Further details regarding specific models and batches are available in the accompanying Medical Device Recall Event Report Form.