# China NMPA Product Recall - LED light curing machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/foshan-skys-medical-equipment-co-ltd/acdb2c69-a669-4d5a-8ddb-1646209d6c92/
Source feed: China

> China NMPA product recall for LED light curing machine by Foshan Skys Medical Equipment Co., Ltd. published August 15, 2022. Recall level: Level 3 Recall. Foshan Skys Medical Device Co., Ltd. has initiated a voluntary Class III recall of its LED Curing Ma

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Foshan Skys Medical Devices Co., Ltd. voluntarily recalls LED light curing machines
- Company Name: Foshan Skys Medical Equipment Co., Ltd.
- Publication Date: 2022-08-15
- Product Name: LED light curing machine
- Recall Level: Level 3 Recall
- Recall Reason: The conducted emission did not meet the requirements during product sampling inspection.
- Discovering Company: Foshan Skys Medical Equipment Co., Ltd.
- Manufacturing Company: Foshan Skys Medical Equipment Co., Ltd.
- Summary: Foshan Skys Medical Device Co., Ltd. has initiated a voluntary Class III recall of its LED Curing Machines, specifically production batch number 2021082401. This action, published by the National Medical Products Administration (NMPA) on August 15, 2022, follows a product sampling inspection conducted under the oversight of the Guangdong Provincial Drug Administration. The primary issue identified was the failure of the LED Curing Machines to meet conduction emission requirements. The recall targets devices with Registration Certificate No.: 粤械注准20192171338. A Class III recall indicates that the use of, or exposure to, a violative product is not likely to cause adverse health consequences. While specific inspection dates are not detailed in the provided information, the recall announcement on August 15, 2022, serves as the effective date for this corrective action. Foshan Skys Medical Device Co., Ltd. is responsible for implementing this recall, which involves retrieving the affected products from the market. The recall process ensures that medical devices adhere to established safety and performance standards set by regulatory bodies like the NMPA, safeguarding public health and maintaining product quality within the medical device industry. Further details are available in the "Medical Device Recall Event Report Form" attached to the original notice.

Company: https://www.globalkeysolutions.net/companies/foshan-skys-medical-equipment-co-ltd/dabcb3dd-8c84-47f4-aa58-d46f23fc94df/