# China NMPA Product Recall - Ultrasonic gastroscopy; electronic upper gastrointestinal endoscopy; electronic colonoscopy; electronic endoscopy for upper gastrointestinal use.

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-trading-shanghai-co-ltd/38d67e2f-c390-4e83-9688-95c4add4ddd9/
Source feed: China

> China NMPA product recall for Ultrasonic gastroscopy; electronic upper gastrointestinal endoscopy; electronic colonoscopy; electronic endoscopy for upper gastrointestinal use. by Olympus Trading (Shanghai) Co., Ltd. published November 06, 2020. Recall level: Level 2 Recall. Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall on November 6, 2020, for 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Trading (Shanghai) Co., Ltd. is voluntarily recalling the following products: electronic gastroscopes, electronic upper gastrointestinal endoscopes, electronic colonoscopes, electronic endoscopes for the upper gastrointestinal tract, and electronic gastroscopes.
- Company Name: Olympus Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-11-06
- Product Name: Ultrasonic gastroscopy; electronic upper gastrointestinal endoscopy; electronic colonoscopy; electronic endoscopy for upper gastrointestinal use.
- Recall Level: Level 2 Recall
- Recall Reason: Complaints regarding the product related to endoscopic ultrasound continue to occur. Reports indicate that even after reprocessing, foreign matter originating from blood or bodily fluids remains in the air and water supply tubing. CAPA's investigation found that following the current instructions for pre-cleaning and reprocessing may not promptly detect issues such as blood or bodily fluid clots.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Trading (Shanghai) Co., Ltd.
- Summary: Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall on November 6, 2020, for several models of its ultrasonic electronic endoscopes, including gastroscopes, upper gastrointestinal endoscopes, and colonoscopes. This action follows persistent complaints regarding the presence of foreign matter, specifically blood or bodily fluids, in the air and water supply tubing of devices such as the GF TYPE UCT260, GF-UCT240/140-AL5, and GF-UC240P-AL5, even after standard reprocessing procedures. The company began a corrective and preventative action (CAPA) investigation into these issues on June 27, 2019. The investigation revealed that existing pre-cleaning and reprocessing instructions might not adequately detect or prevent the retention of blood or body fluid clots. This recall is overseen by the National Medical Products Administration (NMPA) through its Shanghai Municipal Drug Administration. Olympus Trading (Shanghai) Co., Ltd. is actively recalling the affected products, with detailed information on specific models and batches available in the accompanying Medical Device Recall Event Report Form.

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