# China NMPA Product Recall - Electromagnetic field therapy device

Source: https://www.globalkeysolutions.net/records/china_product_recall/guangzhou-longzhijie-technology-co-ltd/908026f7-e678-45eb-bcff-bfb7f03c8a75
Source feed: China

> China NMPA product recall for Electromagnetic field therapy device by Guangzhou Longzhijie Technology Co., Ltd. published December 13, 2018. Recall level: Level 3. Guangzhou Longzhijie Technology Co., Ltd. initiated a Class III voluntary recall of its LGT-2012 Ele

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Guangzhou Longzhijie Technology Co., Ltd. voluntarily recalls electromagnetic field therapy devices.
- Company Name: Guangzhou Longzhijie Technology Co., Ltd.
- Publication Date: 2018-12-13
- Product Name: Electromagnetic field therapy device
- Recall Level: Level 3
- Recall Reason: In July 2018, the Guangzhou Huangpu District Food and Drug Administration found during a random inspection that an electromagnetic field therapy device with production batch number 2012023-2 did not meet the requirements of radiation emission item 36.201.1 and electrical fast transient pulse group 36.202.4 in YY0505-2012.
- Discovering Company: Guangzhou Longzhijie Technology Co., Ltd.
- Manufacturing Company: Guangzhou Longzhijie Technology Co., Ltd.
- Summary: Guangzhou Longzhijie Technology Co., Ltd. initiated a Class III voluntary recall of its LGT-2012 Electromagnetic Field Therapy Devices. This action, reported to the National Medical Products Administration (NMPA) on December 7, 2018, followed a random inspection in July 2018 by the Guangzhou Huangpu District Food and Drug Administration. The inspection revealed that a device from batch 2012023-2 failed to meet specific requirements of standard YY0505-2012. Key violations included non-compliance with radiation emission (item 36.201.1) and electrical fast transient burst (36.202.4) standards. In response, Guangzhou Longzhijie Technology Co., Ltd. implemented several corrective actions. The company issued product information notifications, contacted customers, and recalled all four units from the affected batch, offering replacements with their updated LGT-2000B model. Furthermore, they committed to inspecting the returned devices to ascertain the root cause of the non-conformance and undertake appropriate rectification. The LGT-2012 model has since been discontinued and replaced by the newly registered LGT-2000B, which is stated to resolve the identified issues, ensuring adherence to regulatory standards under the NMPA framework.

Company: https://www.globalkeysolutions.net/companies/guangzhou-longzhijie-technology-co-ltd/da585944-228f-41ca-943c-c0ef7e68ad67