# China NMPA Product Recall - electric wheelchair

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-weizhiqun-electromechanical-products-co-ltd/05f4dbb3-d1cc-48a7-8719-3d77f229f421/
Source feed: China

> China NMPA product recall for electric wheelchair by Shanghai Weizhiqun Electromechanical Products Co., Ltd. published December 11, 2020. Recall level: Level 3 Recall. Shanghai Weizhiqun Electromechanical Products Co., Ltd. initiated a voluntary Level III recall of it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Weizhiqun Electromechanical Products Co., Ltd. has voluntarily recalled electric wheelchairs.
- Company Name: Shanghai Weizhiqun Electromechanical Products Co., Ltd.
- Publication Date: 2020-12-11
- Product Name: electric wheelchair
- Recall Level: Level 3 Recall
- Recall Reason: The issue involves products where the symbols "Application Type B" and "Waterproof Rating" were removed from the label during revisions because their contents were already described in the instruction manual. This results in non-compliance with GB9706.1-2007 requirements for external labeling of equipment.
- Discovering Company: Shanghai Weizhiqun Electromechanical Products Co., Ltd.
- Manufacturing Company: Shanghai Weizhiqun Electromechanical Products Co., Ltd.
- Summary: Shanghai Weizhiqun Electromechanical Products Co., Ltd. initiated a voluntary Level III recall of its electric wheelchairs (Registration Certificate No.: ".NMPA_PRODUCT_RECALL.20162560813), as announced by the National Medical Products Administration (NMPA) on December 11, 2020. The recall stems from labeling deficiencies identified during a label revision process. The primary issue involved the omission of critical symbols, specifically "Type B Application" and "Waterproof Rating," from the external product labeling. While these details were present in the instruction manual, their absence from the external label constitutes a non-conformance with the requirements outlined in GB9706.1-2007, a national standard governing the external labeling of medical electrical equipment. This standard mandates clear and comprehensive external marking to ensure user safety and proper product identification. The company's proactive measure to conduct a voluntary recall underscores its commitment to compliance and product integrity. Detailed information regarding the specific models, specifications, and affected batches is provided in the accompanying "Medical Device Recall Event Report Form," which customers are advised to consult. This recall highlights the importance of adhering to stringent regulatory labeling standards to prevent potential misinterpretation or misuse of medical devices.

Company: https://www.globalkeysolutions.net/companies/shanghai-weizhiqun-electromechanical-products-co-ltd/00debfc5-cdcc-4bbc-b5eb-39cd7738484d/