# China NMPA Product Recall - Specific Electromagnetic Wave (TDP) Therapy Device

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-hualun-hongli-industrial-co-ltd/ac3ef1a1-8e4c-4bd4-ae75-76512d4c5678/
Source feed: China

> China NMPA product recall for Specific Electromagnetic Wave (TDP) Therapy Device by Chongqing Hualun Hongli Industrial Co., Ltd. published April 12, 2021. Recall level: Level 3. Chongqing Hualun Hongli Industrial Co., Ltd. initiated a voluntary Class III recall for specific ele

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Chongqing Hualun Hongli Industrial Co., Ltd. voluntarily recalls specific electromagnetic wave therapy devices.
- Company Name: Chongqing Hualun Hongli Industrial Co., Ltd.
- Publication Date: 2021-04-12
- Product Name: Specific Electromagnetic Wave (TDP) Therapy Device
- Recall Level: Level 3
- Recall Reason: Certain electromagnetic wave therapy devices do not meet the requirements for "voltage and/or energy limitations".
- Discovering Company: Chongqing Hualun Hongli Industrial Co., Ltd.
- Manufacturing Company: Chongqing Hualun Hongli Industrial Co., Ltd.
- Summary: Chongqing Hualun Hongli Industrial Co., Ltd. initiated a voluntary Class III recall for specific electromagnetic wave therapy devices (Model CQH-25A, Batch 1801041) produced on January 9, 2018. This action, reported to the Provincial Food and Drug Administration Department on January 2, 2020, was undertaken because the devices did not meet essential "voltage and/or energy limitations" requirements, posing potential safety hazards. Under the oversight of the National Medical Products Administration (NMPA), the company decided to control defective products and eliminate risks. The regulatory framework involves adherence to medical device standards. As a required action, Chongqing Hualun Hongli Industrial Co., Ltd. issued "Medical Device Recall Notices" to its sales units. Medical institutions and operating units are instructed to follow the requirements outlined in these customer notifications. Notably, this voluntary recall does not entail the physical withdrawal of affected products from the market, suggesting that the corrective action involves notification and potential user-level adjustments rather than product retrieval. This aims to ensure product safety and compliance.

Company: https://www.globalkeysolutions.net/companies/chongqing-hualun-hongli-industrial-co-ltd/078a5e65-54be-455e-926a-e5fbe959ce6b/