# China NMPA Product Recall - Electronic thoracoscope; Electronic thoracoscope (trade name: //); Electronic thoracoscope

Source: https://www.globalkeysolutions.net/records/china_product_recall/overseas-olympus-manufacturing-companies/36f99843-3788-4bb0-aee9-e19ae54cf7c6/
Source feed: China

> China NMPA product recall for Electronic thoracoscope; Electronic thoracoscope (trade name: //); Electronic thoracoscope by Overseas Olympus manufacturing companies published February 10, 2020. Recall level: Level 2 Recall. Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its electronic thorac

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Trading (Shanghai) Co., Ltd. is voluntarily recalling electronic thoracic endoscopes (trade name: //).
- Company Name: Overseas Olympus manufacturing companies
- Publication Date: 2020-02-10
- Product Name: Electronic thoracoscope; Electronic thoracoscope (trade name: //); Electronic thoracoscope
- Recall Level: Level 2 Recall
- Recall Reason: The system diagram in the instruction manual lists biopsy forceps, registration needles, and other endoscopic accessories that are compatible with the electronic thoracic endoscope (LTF). However, as of the date of this report, there is no data to prove that the aforementioned endoscopic accessories are compatible with the electronic thoracic endoscope.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Overseas Olympus manufacturing companies
- Summary: Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its electronic thoracic endoscopes, as announced on February 10, 2020. This action followed a notification from the overseas Olympus manufacturer regarding compatibility issues documented in the product's instruction manual. The core problem identified was that the manual listed various endoscopic accessories, such as biopsy forceps and registration needles, as compatible with the electronic thoracic endoscope (LTF) system. However, at the time of the report, there was insufficient data to substantiate these compatibility claims. This raises concerns about potential risks if unvalidated accessories are used with the device. The recall is being managed under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration (SFDA), reflecting adherence to national medical device regulations. The specific models, specifications, and batches of the impacted electronic thoracic endoscopes are referenced in an accompanying "Medical Device Recall Event Report Form," which would provide further detailed instructions for customers and distributors. This recall underscores the critical importance of accurate and validated product documentation, particularly concerning accessory compatibility, to ensure patient safety and regulatory compliance within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/overseas-olympus-manufacturing-companies/8b8745d9-5060-40f0-a6cf-96a3631ce7a3/