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

Hefei Meiya Optoelectronic Technology Co., Ltd. has initiated a voluntary Class III recall of its "Dental X-ray Digital Computed Tomography Equipment." The recall, publicly reported on June 12, 2019, addresses a critical issue involving the unintended use of the nameplate from a prototype device during the production of commercial units. This error potentially misrepresents the product's status or specifications, raising concerns about regulatory compliance and product identification.

The affected equipment is identified under the registration number CFDA (Approval) No. 20143300400 (Revised). While specific inspection dates are not detailed in this announcement, the recall itself is a regulatory action taken in response to the identified manufacturing discrepancy. The National Medical Products Administration (NMPA) oversees this recall, ensuring that the company adheres to established medical device regulations in China.

As part of the required actions, Hefei Meiya Optoelectronic Technology Co., Ltd. is actively recalling all affected models, specifications, and batches of the dental X-ray equipment. This voluntary action aims to rectify the nameplate issue and maintain product integrity and safety for end-users. Consumers and healthcare providers are directed to the "Medical Device Recall Event Report Form" for detailed information on the specific products involved. The Class III classification indicates a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences.