China NMPA Product Recall - Image archiving and transmission system

On July 30, 2013, GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. initiated a voluntary recall of its Centricity PACS RA1000 image archiving and transmission system. This recall, overseen by China's National Medical Products Administration (NMPA) and its provincial food and drug administration bureaus, addresses a critical software defect. The main issue stems from the workstation's inaccurate calculation of distance measurements. The software incorrectly includes values from DICOM tags for imager pixel pitch and magnification factor (0018, 1164 and 0018, 1114 respectively) but excludes the crucial pixel pitch tag (0020, 0030), resulting in potentially erroneous measurement values for medical images. Awareness of this issue dates back to October 2011, with subsequent complaints in early 2013. However, no actual serious injuries or deaths have been reported or deemed probable. GE Healthcare has outlined two primary corrective actions. First, a user notification will be sent to customers, advising them to incorporate known-sized objects in images to facilitate accurate manual distance calibration, with the system indicating calibration status. Second, an on-site software upgrade will be performed by a service engineer. This software upgrade is pending registration approval and will be implemented upon completion of that process, with GE Healthcare committed to submitting a detailed progress report to the NMPA.