# China NMPA Product Recall - Digital dental X-ray tomography equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/hefei-meiya-optoelectronic-technology-co-ltd/37e59acc-774d-4328-bb5b-7d0f5ee744a7/
Source feed: China

> China NMPA product recall for Digital dental X-ray tomography equipment by Hefei Meiya Optoelectronic Technology Co., Ltd. published June 12, 2019. Recall level: Level 3. Hefei Meiya Optoelectronic Technology Co., Ltd. initiated a voluntary Class III recall for its "Digi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hefei Meiya Optoelectronic Technology Co., Ltd. voluntarily recalls dental X-ray digital tomography equipment
- Company Name: Hefei Meiya Optoelectronic Technology Co., Ltd.
- Publication Date: 2019-06-12
- Product Name: Digital dental X-ray tomography equipment
- Recall Level: Level 3
- Recall Reason: Reasons for unintended use of the prototype nameplate during R&D
- Discovering Company: Hefei Meiya Optoelectronic Technology Co., Ltd.
- Manufacturing Company: Hefei Meiya Optoelectronic Technology Co., Ltd.
- Summary: Hefei Meiya Optoelectronic Technology Co., Ltd. initiated a voluntary Class III recall for its "Digital Tomometry Equipment for Dental X-rays," identified under CFDA Approval No. 20143300400(Revised). The National Medical Products Administration (NMPA) and Anhui Provincial Drug Administration Website announced this recall on June 12, 2019. The primary issue leading to the recall was the unintended use of a nameplate belonging to a prototype device still under development. This labeling discrepancy affects specific models, specifications, and batch numbers, with detailed information available in the company's Medical Device Recall Event Report Form. As a required action, the company is systematically withdrawing the affected products from the market to correct the non-compliance related to product identification. The Class III designation signifies that the product defect is unlikely to cause adverse health consequences, yet the company must identify and retrieve all impacted units to rectify the labeling error, ensuring regulatory standards for medical device accuracy and proper identification are met.

Company: https://www.globalkeysolutions.net/companies/hefei-meiya-optoelectronic-technology-co-ltd/4fff621f-d822-4c32-b874-24fb630e79c8/