# China NMPA Product Recall - Intermediate frequency therapy device

Source: https://www.globalkeysolutions.net/records/china_product_recall/beijing-dongjie-huayi-medical-device-co-ltd/e09c5958-6f06-40c9-ab61-2ba86c8b2258/
Source feed: China

> China NMPA product recall for Intermediate frequency therapy device by Beijing Dongjie Huayi Medical Device Co., Ltd. published October 08, 2019. Recall level: Level 3 Recall. Beijing Dongjie Huayi Medical Device Co., Ltd. initiated a Level III voluntary recall for its Interm

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beijing Dongjie Huayi Medical Device Co., Ltd. voluntarily recalls intermediate frequency therapy devices.
- Company Name: Beijing Dongjie Huayi Medical Device Co., Ltd.
- Publication Date: 2019-10-08
- Product Name: Intermediate frequency therapy device
- Recall Level: Level 3 Recall
- Recall Reason: Of the inspected items, 6.1q) does not meet the requirements of the YZB/京0954-2013 registered product standard, and 6.1n and the durability of the equipment markings do not meet the requirements of the YZB/京0954-2013 registered product standard and the national standard GB9706.1-2007.
- Discovering Company: Beijing Dongjie Huayi Medical Device Co., Ltd.
- Manufacturing Company: Beijing Dongjie Huayi Medical Device Co., Ltd.
- Summary: Beijing Dongjie Huayi Medical Device Co., Ltd. initiated a Level III voluntary recall for its Intermediate Frequency Therapy Devices (batch 2018DH02), as formally reported on September 20, 2019, and published by the National Medical Products Administration (NMPA) on October 8, 2019. The recall stemmed from non-compliance with established regulatory and product standards. Specifically, the devices failed to meet requirements outlined in the YZB/京0954-2013 registered product standard concerning physiological effects, including symbols and warnings (item 6.1q). Additionally, the durability of the device's markings and the accessibility and clear marking of fuses (item 6.1n) did not conform to both the YZB/京0954-2013 standard and the GB9706.1-2007 national standard. In response, the company undertook corrective actions, notifying the three affected product users by phone and retrieving the devices. The non-compliant paper material used for product markings was replaced with more durable PVC material to ensure compliance. These corrections were also formally noted on the product's certificate of conformity, reinforcing the company's commitment to regulatory adherence and product safety standards within the Chinese market.

Company: https://www.globalkeysolutions.net/companies/beijing-dongjie-huayi-medical-device-co-ltd/9f1e8b53-a003-4322-8fef-34da4de0c3d0/