# China NMPA Product Recall - Electronic upper gastrointestinal endoscope

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-medical-corporation/495fcf4e-eaa7-405f-9b13-1f78152c059b/
Source feed: China

> China NMPA product recall for Electronic upper gastrointestinal endoscope by Olympus Medical Corporation published July 14, 2023. Recall level: Level 3 Recall. On July 14, 2023, the National Medical Products Administration (NMPA) announced a voluntary Class II

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Medical Corporation voluntarily recalls electronic upper gastrointestinal endoscopes and other products.
- Company Name: Olympus Medical Corporation
- Publication Date: 2023-07-14
- Product Name: Electronic upper gastrointestinal endoscope
- Recall Level: Level 3 Recall
- Recall Reason: Some products lack final inspection standards.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Medical Corporation
- Summary: On July 14, 2023, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Olympus Medical Products Corporation. This action, reported by Olympus Trading (Shanghai) Co., Ltd., primarily involves several electronic medical devices, including various models of electronic gastroscopes, colonoscopes, duodenoscopes, and upper gastrointestinal endoscopes. The main issue identified leading to this recall is the absence of established final inspection work standards for some of these products. This deficiency indicates a gap in the quality assurance processes intended to ensure product conformance prior to market release. Operating within the NMPA's regulatory framework for medical devices in China, Olympus is proactively taking this measure to address the non-conformance. A Class III recall typically signifies that the use of or exposure to the affected product is not likely to cause adverse health consequences. This voluntary recall demonstrates the company's commitment to upholding product safety and regulatory compliance by withdrawing potentially compromised batches from circulation.

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