China NMPA Product Recall - Radiotherapy planning system

Varian Medical Systems, Inc., via its Chinese subsidiary Varian Medical Devices (China) Co., Ltd., initiated a voluntary Class III recall of its Eclipse Radiotherapy Planning System, published by the National Medical Products Administration (NMPA) on February 23, 2016. The core issue involves an inconsistency in the machine hop count (MU) of the dose calculation. This defect occurs when generating conventional arc field doses with over 100 subfields, specifically in Eclipse versions 11, 13, 13.5, and 13.6 that utilize the PBC 11.0.31 algorithm. Importantly, Varian has confirmed that no reports of actual improper dose delivery to patients have been received due to this software anomaly. The problem does not affect Eclipse versions 10 and earlier, or versions 11-13.6 using PBC 10.0.28, nor RapidArc or TrueBeam arc planning. As part of the required actions under this regulatory framework, Varian has proactively informed all potentially impacted global customers. The company is actively engaged in developing and implementing a corrective solution to resolve the identified software issue and uphold the safety and integrity of radiotherapy planning.