China NMPA Product Recall - LED light curing machine

The National Medical Products Administration (NMPA) has announced a voluntary Class III recall initiated by Ivoclar Vivadent AG for its LED curing machines. As reported by Ivoclar Vivadent (Shanghai) Trading Co., Ltd. on February 29, 2024, the recall addresses a critical product deficiency stemming from errors in the manufacturing process. These errors led to the light intensity of the affected LED curing machines exceeding established safety standards. The devices involved are registered under National Medical Device Registration Certificate No. 20172556837.

Ivoclar Vivadent AG is undertaking this recall to address the potential risks associated with the non-conforming light intensity. While specific inspection dates are not detailed, the company proactively reported the manufacturing flaw and its subsequent recall action. This measure falls under the NMPA's regulatory oversight for medical devices in China. The primary required action is the voluntary retrieval of all impacted LED curing machine models, specifications, and batches, with further details available in an attached Medical Device Recall Event Report Form, ensuring patient safety and compliance with medical device regulations.