# China NMPA Product Recall - Electronic duodenoscope

Source: https://www.globalkeysolutions.net/records/china_product_recall/hoya-co-ltd/571a2f57-c3d5-4428-86e8-40f89e6dbf5d/
Source feed: China

> China NMPA product recall for Electronic duodenoscope by HOYA Co., Ltd. published December 07, 2016. Recall level: Level II. Pentax Medical Devices (Shanghai) Co., Ltd. initiated a Class II voluntary recall for 55 units of it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Pentax Medical Devices (Shanghai) Co., Ltd. voluntarily recalls electronic duodenoscopes
- Company Name: HOYA Co., Ltd.
- Publication Date: 2016-12-07
- Product Name: Electronic duodenoscope
- Recall Level: Level II
- Recall Reason: Due to their complex design, some electronic duodenoscopes may experience reduced disinfection effectiveness if cleaning and disinfection are not performed strictly according to the instruction manual, resulting in the failure to remove contaminants in a timely manner. However, to date, no injuries have been reported.
- Discovering Company: Pentax Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: HOYA Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/hoya-co-ltd/783a5bf7-2b2f-429f-abe6-aa5269521586/