# China NMPA Product Recall - box-type hearing aids

Source: https://www.globalkeysolutions.net/records/china_product_recall/xiamen-xinsheng-technology-co-ltd/50d27327-5f5b-4f1c-8019-c738b3b66b38/
Source feed: China

> China NMPA product recall for box-type hearing aids by Xiamen Xinsheng Technology Co., Ltd. published November 07, 2018. Recall level: Level 3 Recall. Xiamen Xinsheng Technology Co., Ltd. initiated a voluntary Class III recall of its box-type hearing 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Xiamen Xinsheng Technology Co., Ltd. initiates voluntary recall of its box-type hearing aids
- Company Name: Xiamen Xinsheng Technology Co., Ltd.
- Publication Date: 2018-11-07
- Product Name: box-type hearing aids
- Recall Level: Level 3 Recall
- Recall Reason: Some products have rated current consumption exceeding the company's standard.
- Discovering Company: Xiamen Xinsheng Technology Co., Ltd.
- Manufacturing Company: Xiamen Xinsheng Technology Co., Ltd.
- Summary: Xiamen Xinsheng Technology Co., Ltd. initiated a voluntary Class III recall of its box-type hearing aids, as reported by the National Medical Products Administration (NMPA) on November 7, 2018. The company filed the Medical Device Recall Event Report Form on October 15, 2018. The primary reason for this recall stemmed from product quality issues, specifically that some units exhibited "rated current consumption" levels exceeding the company's established internal standards. This deviation suggests a potential non-conformance with design or manufacturing specifications, which could impact device performance or user experience, though a Class III recall indicates the likelihood of adverse health consequences is not significant. This action falls under the regulatory oversight of the NMPA, which governs medical device safety and quality in China. While the document does not detail specific inspection dates, the voluntary recall mechanism is a critical component of the NMPA's framework for ensuring product compliance and public safety. Xiamen Xinsheng Technology Co., Ltd. was required to identify and address the affected products, with further details on specific models, specifications, and batch numbers provided in the recall report form. The company's proactive recall demonstrates adherence to regulatory responsibilities, aiming to mitigate any potential risks associated with the non-conforming hearing aids.

Company: https://www.globalkeysolutions.net/companies/xiamen-xinsheng-technology-co-ltd/a7170618-0f7b-4a64-85dc-70bc4e558e56/