China NMPA Product Recall - Magnetic Resonance Imaging System

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of various Magnetic Resonance Imaging (MRI) Systems, as reported to the National Medical Products Administration (NMPA) on September 28, 2016. This action followed a recall notice from its CADStream component supplier, Merge Healthcare, a subsidiary of IBM Company. The recall was prompted by identified defects affecting the SureLoc and PURE functions of the CADStream components.

The primary issues include: in the SureLoc application, incorrect grid selection or the use of unsupported grids could lead to inaccurate or missed biopsy targets. Additionally, the PURE function, specifically for CADStream versions prior to March 2008 (manufactured by Confirma, Inc., CADstream 5.2.6 and later), was found to potentially affect image signal strength. This could cause color changes in the CADStream Angiomap during dynamic MRI studies, risking delays in patient diagnosis or treatment.

Under the NMPA regulatory framework, GE Healthcare is responsible for all recall actions in China. The required actions involve sending customer letters to inform them of the issue and provide instructions for safe CADStream usage until corrective measures are implemented. Furthermore, GE Healthcare will dispatch engineers to perform free, on-site corrective actions on all affected MRI systems, which include various models of Advantage Workstation and Signa MRI systems.