# China NMPA Product Recall - Electronic bronchoscope (trade name: EVIS EXERA II)

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-trading-shanghai-co-ltd/058abcee-0be7-41ec-bdb2-bd58d8e096ae/
Source feed: China

> China NMPA product recall for Electronic bronchoscope (trade name: EVIS EXERA II) by Olympus Trading (Shanghai) Co., Ltd. published September 09, 2020. Recall level: Level 2 Recall. On September 9, 2020, Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Trading (Shanghai) Co., Ltd. is voluntarily recalling its electronic bronchoscope (trade name: EVIS EXERA Ⅱ).
- Company Name: Olympus Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-09-09
- Product Name: Electronic bronchoscope (trade name: EVIS EXERA II)
- Recall Level: Level 2 Recall
- Recall Reason: The issue involves the BF-1T180 bronchoscope, which, according to Olympus' internal post-market risk assessment, had a higher probability of causing patient infection compared to other Olympus bronchoscopes.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Trading (Shanghai) Co., Ltd.
- Summary: On September 9, 2020, Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its electronic bronchoscope, specifically the EVIS EXERA II model (Registration Certificate No.: CFDA (Imported) 2012 No. 3221125). This action was taken following an internal post-marketing risk assessment that identified a higher probability of patient infection associated with the BF-1T180 bronchoscope, a component within the EVIS EXERA II system, compared to other Olympus bronchoscope models. The recall, indexed as Shanghai Drug Administration Recall 2020-173, operates under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The required action involves the systematic removal of the affected devices from circulation to mitigate potential health risks. Detailed information regarding specific affected product models, specifications, and batches is accessible through the accompanying "Medical Device Recall Event Report Form" provided by the company.

Company: https://www.globalkeysolutions.net/companies/olympus-trading-shanghai-co-ltd/510963e8-8b01-4884-b017-bc21b376ca33/