# China NMPA Product Recall - Infrared spectrum therapy device

Source: https://www.globalkeysolutions.net/records/china_product_recall/rongjie-health-technology-co-ltd-formerly-known-as-anhui-lg-health-technology-co-ltd/f252e227-c1c0-494b-9867-7bdfb579374c/
Source feed: China

> China NMPA product recall for Infrared spectrum therapy device by Rongjie Health Technology Co., Ltd. (formerly known as Anhui LG Health Technology Co., Ltd.) published September 03, 2019. Recall level: Level 3 Recall. Rongjie Health Technology Co., Ltd., formerly Anhui LG Health Technology Co., Ltd., initiated a volu

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Rongjie Health Technology Co., Ltd. (formerly Anhui LG Health Technology Co., Ltd.) has voluntarily recalled its infrared spectrum therapy devices.
- Company Name: Rongjie Health Technology Co., Ltd. (formerly known as Anhui LG Health Technology Co., Ltd.)
- Publication Date: 2019-09-03
- Product Name: Infrared spectrum therapy device
- Recall Level: Level 3 Recall
- Recall Reason: The "Instructions for Use" and other documents (see the "Medical Device Recall Event Report Form") did not meet the requirements of the inspection items for "30250. Specific Electromagnetic Wave Therapy Device" in the "2019 National Medical Device Sampling Inspection (Central Government Subsidized Local Project) Product Inspection Plan" (Document No. 1 of 2019) issued by the State Food and Drug Administration.
- Discovering Company: Rongjie Health Technology Co., Ltd. (formerly known as Anhui LG Health Technology Co., Ltd.)
- Manufacturing Company: Rongjie Health Technology Co., Ltd. (formerly known as Anhui LG Health Technology Co., Ltd.)
- Summary: Rongjie Health Technology Co., Ltd., formerly Anhui LG Health Technology Co., Ltd., initiated a voluntary Level III recall for its infrared spectrum therapy devices. This action stemmed from findings during the 2019 National Medical Device Sampling Inspection, which identified that the product's "Instructions for Use" did not meet the specified requirements. Specifically, the non-compliance was noted under inspection item "30250. Specific Electromagnetic Wave Therapy Device," as outlined in the 2019 National Medical Device Sampling Inspection Product Inspection Plan. The National Medical Products Administration (NMPA) publicized this recall on September 3, 2019, with the recall event reported on September 2, 2019. The affected devices were registered under certificate number 

皖械注准20142260015. The required action by the company was a voluntary recall of these devices. A Level III recall typically signifies that the use of, or exposure to, the non-compliant product is unlikely to cause adverse health consequences. Detailed information concerning specific models, specifications, and batch numbers is provided in the associated Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/rongjie-health-technology-co-ltd-formerly-known-as-anhui-lg-health-technology-co-ltd/bcf6da95-cbc8-48da-9858-c32d84ea2732/