# China NMPA Product Recall - Specific electromagnetic wave therapy device

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-hualun-medical-equipment-co-ltd/6a89e42b-0ebc-4968-ba5c-ca6b7269bf97/
Source feed: China

> China NMPA product recall for Specific electromagnetic wave therapy device by Chongqing Hualun Medical Equipment Co., Ltd. published January 22, 2020. Recall level: Level 3 Recall. Chongqing Hualun Medical Device Co., Ltd. initiated a voluntary Class III recall of specific electro

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Chongqing Hualun Medical Equipment Co., Ltd. voluntarily recalls certain electromagnetic wave therapy devices.
- Company Name: Chongqing Hualun Medical Equipment Co., Ltd.
- Publication Date: 2020-01-22
- Product Name: Specific electromagnetic wave therapy device
- Recall Level: Level 3 Recall
- Recall Reason: Some electromagnetic wave therapy devices do not meet the requirement that "the device should not become unbalanced when tilted at 10° during normal use," posing a safety hazard.
- Discovering Company: Chongqing Hualun Medical Equipment Co., Ltd.
- Manufacturing Company: Chongqing Hualun Medical Equipment Co., Ltd.
- Summary: Chongqing Hualun Medical Device Co., Ltd. initiated a voluntary Class III recall of specific electromagnetic wave therapy devices (Registration Certificate 20162260108). The recall, reported on January 2, 2020, and published by the National Medical Products Administration (NMPA) on January 22, 2020, addresses a critical safety concern. The affected devices, specifically model CQJ-25B with production batch number 1810259, manufactured on October 29, 2018 (50 units), failed to meet the regulatory requirement of maintaining balance when tilted at 10 degrees during normal operation. This instability poses a potential safety hazard during use. Operating under the oversight of the NMPA and the Sichuan Provincial Drug Administration, the company's corrective actions include distributing "Medical Device Recall Notices" to all sales points. These notices mandate that all medical institutions and operating units immediately cease selling the affected products and promptly return them to Chongqing Hualun Medical Device Co., Ltd. for necessary rework. This voluntary recall aims to effectively control the distribution of defective products and mitigate identified safety risks.

Company: https://www.globalkeysolutions.net/companies/chongqing-hualun-medical-equipment-co-ltd/3dd387c0-c64b-43f7-ae61-825360186cb5/