# China NMPA Product Recall - Dental light curing machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/dentlight-inc/281a2ae6-b0e3-4921-a7ca-5e4150388363
Source feed: China

> China NMPA product recall for Dental light curing machine by DENTLIGHT INC. published January 17, 2019. Recall level: Level 3 Recall. DENTLIGHT INC. has initiated a voluntary Class III recall of its Dental Cure-Intensive Light (DILI) 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: DENTLIGHT INC. is voluntarily recalling dental light-curing units.
- Company Name: DENTLIGHT INC.
- Publication Date: 2019-01-17
- Product Name: Dental light curing machine
- Recall Level: Level 3 Recall
- Recall Reason: The 2018 national random inspection results showed that the external markings of the equipment or its components did not comply with GB9706.1-2017 Medical Electrical Equipment Part 1: Safety - General Purpose, and the continuous leakage current and patient assist current measurements at operating temperature were 0.136 mA, exceeding the allowable value of 0.1 mA listed in Table 4 of GB9706.1.
- Discovering Company: Beijing Guqi Health Technology Co., Ltd.
- Manufacturing Company: DENTLIGHT INC.
- Summary: DENTLIGHT INC. has initiated a voluntary Class III recall of its Dental Cure-Intensive Light (DILI) machines (Registration No.: 20162551854). This action follows findings from a 2018 national random inspection. The inspection revealed two primary compliance issues with the medical devices. Firstly, the external markings on the DILI machines or their components were found to be non-compliant with the requirements outlined in GB9706.1-2017, a standard for Medical Electrical Equipment Safety. Secondly, testing at operating temperature showed the continuous leakage current and patient auxiliary current measurement value to be 0.136mA. This measurement exceeded the maximum allowable limit of 0.1mA, as specified in Table 4 of the same GB9706.1 standard. In response to these significant safety and compliance deviations, DENTLIGHT INC. is undertaking this recall in accordance with the National Medical Products Administration's (NMPA) "Regulations on the Recall of Medical Devices." Affected models, specifications, and batches are detailed in the "Medical Device Recall Form." This recall emphasizes the importance of adherence to national safety standards for medical electrical equipment to ensure patient safety and product reliability.

Company: https://www.globalkeysolutions.net/companies/dentlight-inc/422b4c9f-a6bd-4941-86ed-5c2743d9d3a1