# China NMPA Product Recall - Ultrasonic electronic bronchoscope; Ultrasonic fiber optic electronic bronchoscope; Ultrasonic bronchoscope

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-trading-shanghai-co-ltd/892293fd-5b53-4337-a4de-382014095774/
Source feed: China

> China NMPA product recall for Ultrasonic electronic bronchoscope; Ultrasonic fiber optic electronic bronchoscope; Ultrasonic bronchoscope by Olympus Trading (Shanghai) Co., Ltd. published March 03, 2021. Recall level: Level 3. Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Ultrasonic Electr

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Trading (Shanghai) Co., Ltd. is voluntarily recalling its ultrasonic electronic bronchoscope and ultrasonic fiber optic electronic bronchoscope.
- Company Name: Olympus Trading (Shanghai) Co., Ltd.
- Publication Date: 2021-03-03
- Product Name: Ultrasonic electronic bronchoscope; Ultrasonic fiber optic electronic bronchoscope; Ultrasonic bronchoscope
- Recall Level: Level 3
- Recall Reason: The issue involves discrepancies between the manufacturing address of the water bag MAJ-1351, an accessory product of the ultrasonic electronic bronchoscope, and the actual manufacturing address described in the medical device registration certificate for that accessory product.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Trading (Shanghai) Co., Ltd.
- Summary: Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Ultrasonic Electronic Bronchoscope and Ultrasonic Fiber Optic Electronic Bronchoscope products, along with the add-on product MAJ-1351, as announced on March 3, 2021. The recall stems from a critical discrepancy identified between the production address listed on the medical device registration certificates (Nos.: 20153061606; 20153221606) and the actual production site for the MAJ-1351 add-on product. This issue, involving non-compliance with registered production details, prompted the company to take immediate corrective action. The recall was reported via the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, underscoring adherence to medical device regulatory requirements in China. Affected product models, specifications, and batch information are detailed in an accompanying "Medical Device Recall Event Report Form," indicating the scope and required actions for this regulatory matter.

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