# China NMPA Product Recall - surgical microscope

Source: https://www.globalkeysolutions.net/records/china_product_recall/zhenjiang-yihua-optical-instrument-co-ltd/ffebaa8e-ad80-4e7d-9867-64b3aeac59f8/
Source feed: China

> China NMPA product recall for surgical microscope by Zhenjiang Yihua Optical Instrument Co., Ltd. published December 11, 2018. Recall level: Level 3. Zhenjiang Yihua Optical Instrument Co., Ltd. initiated a Level 3 voluntary recall for its TH-X-4A Su

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zhenjiang Yihua Optical Instrument Co., Ltd. voluntarily recalls surgical microscopes
- Company Name: Zhenjiang Yihua Optical Instrument Co., Ltd.
- Publication Date: 2018-12-11
- Product Name: surgical microscope
- Recall Level: Level 3
- Recall Reason: In the 2018 national medical device spot check, the "external marking of equipment or equipment parts" item did not meet the standard requirements, specifically the items "the location of the bulb replacement and the cross arm lifting safety device lacked appropriate markings for the corresponding dangers" and "the power supply current type was not marked".
- Discovering Company: Zhenjiang Yihua Optical Instrument Co., Ltd.
- Manufacturing Company: Zhenjiang Yihua Optical Instrument Co., Ltd.
- Summary: Zhenjiang Yihua Optical Instrument Co., Ltd. initiated a Level 3 voluntary recall for its TH-X-4A Surgical Microscopes (Registration Certificate Code: Su Xie Zhu Zhun 20142220213). This action followed a National Medical Device Spot Check conducted by the Pharmaceutical and Instrument Testing Institute between May 25 and September 4, 2018. The inspection identified critical non-compliance issues concerning the equipment's external markings. Specifically, the sample unit was found to have a "missing bulb position and horizontal arm lifting safety device," "inadequate marking of corresponding hazards," and an "unmarked power supply current type." Operating under the National Medical Products Administration (NMPA) framework, the company's required corrective actions include replacing non-compliant labels with new ones and significantly strengthening finished product inspection procedures to mitigate product risks and ensure regulatory adherence. Importantly, the single affected unit was a sample and had not been sold to the public, remaining with the testing institute.

Company: https://www.globalkeysolutions.net/companies/zhenjiang-yihua-optical-instrument-co-ltd/8dc086c9-ec05-452d-aa80-588b55a411a4/