China NMPA Product Recall - Electronic duodenoscope

Pentax Medical Devices (Shanghai) Co., Ltd. initiated a Class II voluntary recall for 55 units of its ED-3490TK electronic duodenoscopes in China, as reported on September 9, 2016, and publicly announced by the National Medical Products Administration (NMPA) on December 7, 2016. The recall stems from the complex structural design of these medical devices. This design characteristic poses a risk where, if cleaning and disinfection protocols are not strictly followed according to instructions, contaminants may not be effectively removed, potentially increasing patient risk. Although no patient injuries have been reported, the company identified a concern regarding reduced disinfection effectiveness. Under the regulatory oversight of the NMPA, referencing the CFDA (Imported) 2013 No. 3223380 registration, Pentax Medical has taken corrective actions. These actions include issuing formal notification letters to all affected customers. These letters emphasize the critical importance of adhering to standardized cleaning and disinfection procedures for the duodenoscopes. Furthermore, after-sales service engineers are deployed to provide on-site supervision and guidance on the key operational steps for cleaning and disinfecting these devices, ensuring proper usage and patient safety.