China NMPA Product Recall - Radiotherapy planning system

The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Varian Medical Systems, Inc., with the issue reported by its subsidiary Varian Medical Devices (China) Co., Ltd. Published on February 23, 2016, this recall addresses a critical concern within the company's radiotherapy planning system. The primary issue identified was an inconsistency in the machine hop count (MU) of the dose when calculating conventional arc field doses comprising more than 100 subfields. This defect specifically impacted systems utilizing the PBC 11.0.31 algorithm within Eclipse software versions 11, 13, 13.5, or 13.6. Varian confirmed that no reports of actual improper dose delivery directly attributable to this software anomaly had been received. The recall aims to mitigate potential risks associated with this software discrepancy, with affected products under Registration or Filing No.: 国械注进 20153700987. Unaffected systems include Eclipse versions 10 and earlier, as well as specific algorithm versions like PBC 10.0.28, and other planning modalities such as RapidArc and TrueBeam. The document did not specify any inspection dates, focusing on the company's voluntary action to ensure device safety and accuracy.