# China NMPA Product Recall - Specific electromagnetic wave therapy device

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-hualun-medical-equipment-co-ltd/8d0c5dd4-6f0a-4bbf-b2ee-15884df99e76/
Source feed: China

> China NMPA product recall for Specific electromagnetic wave therapy device by Chongqing Hualun Medical Equipment Co., Ltd. published October 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. has initiated a voluntary recall of certain electromagnetic wave therapy devices (1812323).
- Company Name: Chongqing Hualun Medical Equipment Co., Ltd.
- Publication Date: 2020-10-22
- Product Name: Specific electromagnetic wave therapy device
- Recall Level: Level 3 Recall
- Recall Reason: Certain electromagnetic wave therapy devices do not meet the requirement that "the device should not become unbalanced when tilted at 10° during normal use".
- 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 code 渝械注准20162260108), identified by production batch number 1812323, manufactured on December 28, 2018. This recall, reported on January 2, 2020, and published by the National Medical Products Administration (NMPA) on October 22, 2020, addresses a critical safety concern. The primary issue discovered was that the affected devices failed to meet the essential safety requirement of maintaining balance when tilted at 10° during normal operation, posing a potential hazard to users. Fifty units of model CQJ-25B were impacted and sold within China. Under the regulatory oversight of the NMPA, Chongqing Hualun Medical Device Co., Ltd. is undertaking specific corrective actions. These include distributing "Medical Device Recall Notices" to all relevant sales points, mandating that medical institutions and operating units immediately cease sales of the affected products upon receipt of the notice, and facilitating the prompt return of these devices to the company for necessary rework to resolve the identified imbalance issue.

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