China NMPA Product Recall - Magnetic Resonance Imaging System

Siemens Healthineers initiated a voluntary Class III recall of its Magnetic Resonance Imaging Systems (MRI Systems) on February 13, 2019, as reported by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall was prompted by regulatory changes that necessitated an update to the product labels. Specifically, the original labels on the equipment required replacement with new versions that include essential information such as the agent's name, address, contact details, and product expiration date. This action ensures compliance with the updated regulatory framework. Affected products include MRAs with specific registration certificate numbers (CFDA (Imported) 2014 No. 3282943, CFDA (Imported) 20153283844, CFDA (Imported) 2014 No. 3284816). Detailed information regarding the affected models and batches is available in the company's Medical Device Recall Report Form. Siemens Healthineers' proactive measure addresses the labeling discrepancy to meet current regulatory standards.