# China NMPA Product Recall - Electronic upper gastrointestinal endoscope

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-medical-corporation/76d75a7b-529a-4228-9bc3-3588969328b2/
Source feed: China

> China NMPA product recall for Electronic upper gastrointestinal endoscope by Olympus Medical Corporation published October 08, 2024. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) issued a notice on October 8, 2024, detailing a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Medical Corporation voluntarily recalls electronic upper gastrointestinal endoscopes
- Company Name: Olympus Medical Corporation
- Publication Date: 2024-10-08
- Product Name: Electronic upper gastrointestinal endoscope
- Recall Level: Level 3 Recall
- Recall Reason: Sterilization packaging lacks product information
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Medical Corporation
- Summary: The National Medical Products Administration (NMPA) issued a notice on October 8, 2024, detailing a voluntary Class III recall by Olympus Medical Systems, Inc. for its electronic upper gastrointestinal endoscopes. The recall was initiated due to the discovery of missing critical product information on the sterilized packaging of these devices. Olympus Trading (Shanghai) Co., Ltd. reported this issue to the NMPA. A Class III recall indicates that the use of, or exposure to, the affected product is unlikely to cause adverse health consequences. It is noteworthy that while the manufacturer initiated this recall, the specific batches of the affected endoscopes were not imported into the Chinese market. The regulatory framework for this action falls under the NMPA's medical device oversight. Detailed information regarding specific models, specifications, and batch numbers is available in the 'Medical Device Recall Event Report Form.' This action emphasizes the importance of precise labeling and packaging adherence to ensure patient safety and regulatory compliance within the medical device sector.

Company: https://www.globalkeysolutions.net/companies/olympus-medical-corporation/527e2e59-6901-42c2-a360-40be55f6edb8/