# China NMPA Product Recall - Ultrasonic bronchial endoscopy; ultrasonic gastroscopy; ultrasonic upper gastrointestinal endoscopy; ultrasonic upper gastrointestinal endoscopy

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-trading-shanghai-co-ltd/6a22d9b9-7f28-4b0b-8b7f-971c9e6a793e/
Source feed: China

> China NMPA product recall for Ultrasonic bronchial endoscopy; ultrasonic gastroscopy; ultrasonic upper gastrointestinal endoscopy; ultrasonic upper gastrointestinal endoscopy by Olympus Trading (Shanghai) Co., Ltd. published October 19, 2021. Recall level: Level 3 Recall. Olympus Trading (Shanghai) Co., Ltd. has initiated a voluntary Class III recall of its electronic br

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Trading (Shanghai) Co., Ltd. is voluntarily recalling the following products: electronic bronchoscope, electronic gastroscope, electronic upper gastrointestinal endoscope.
- Company Name: Olympus Trading (Shanghai) Co., Ltd.
- Publication Date: 2021-10-19
- Product Name: Ultrasonic bronchial endoscopy; ultrasonic gastroscopy; ultrasonic upper gastrointestinal endoscopy; ultrasonic upper gastrointestinal endoscopy
- Recall Level: Level 3 Recall
- Recall Reason: The issue stems from a software version change in the endoscope ID card for the product. Starting in October 2016, the software version was changed from Ver 1.00 to Ver 2.02. This software update was not approved for modification of the medical device registration certificate before the product containing the new software version was launched in the Chinese market. Consequently, the Ver 2.02 products on the market do not match the information on the product's medical device registration certificate.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Trading (Shanghai) Co., Ltd.
- Summary: Olympus Trading (Shanghai) Co., Ltd. has initiated a voluntary Class III recall of its electronic bronchoscopes, electronic gastroscopes, and upper gastrointestinal endoscopes. This action, reported by the National Medical Products Administration (NMPA) on October 19, 2021, addresses a significant regulatory non-compliance. The main issue involves an unauthorized software update made in October 2016, where the endoscope ID card software was changed from Version 1.00 to Version 2.02. Critically, this software revision was not submitted for regulatory approval before products containing the updated version were introduced into the Chinese market. As a result, the products currently on the market with Version 2.02 differ from the specifications detailed in their official medical device registration certificates. Operating under the NMPA's regulatory framework, Olympus is taking required actions to recall the affected devices, identified by registration certificate numbers 20153061606, 20153063719, 20163063057, and 20163063147. Comprehensive details regarding specific models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form." This recall ensures market compliance and product integrity.

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