China NMPA Product Recall - fundus camera

Carl Zeiss Meditec, Inc., based in the USA, in collaboration with Carl Zeiss (Shanghai) Management Co., Ltd., initiated a voluntary Class III recall of specific models and batches of its fundus cameras. This action was announced on April 15, 2021, under the regulatory oversight of the National Medical Products Administration (NMPA). The core issue prompting this recall is a identified problem with the automatic import function within the affected fundus cameras. While the specific implications of this malfunction are not detailed in the public notice, a Class III recall typically indicates that the use of or exposure to the affected product is not likely to cause adverse health consequences. As a required action, the manufacturer is undertaking a voluntary recall to address this product deficiency. Detailed information regarding the affected product models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form."