China NMPA Product Recall - Magnetic Resonance Imaging System

GE Healthcare Systems Co., Ltd., through its entity Hangwei General Electric Medical Systems Co., Ltd., initiated a voluntary Class III recall of various Magnetic Resonance Imaging (MRI) systems. This action was published by the National Medical Products Administration (NMPA) on December 10, 2018. The recall stems from internal inspections by GE Healthcare, which uncovered that the most recent field software version might not have been reinstalled on some systems following service activities that necessitated software reloading. Affected models, including Brivo MR355, Optima MR360, and Signa EXCITE 0.2T, impact 315 units sold in China, as well as units in other countries like Canada and Japan. While no patient injuries have been reported, the company is proactively addressing the issue to uphold safety and quality standards. The required actions involve sending direct email notifications to customers about the software discrepancy and deploying GE Healthcare engineers to conduct complimentary on-site repairs for all identified affected products.