China NMPA Product Recall - Radiotherapy planning system

Varian Medical Systems, Inc., in conjunction with its Chinese affiliate Varian Medical Devices (China) Co., Ltd., initiated a global Class III voluntary recall for its Eclipse Radiotherapy Planning System. Publicly reported on July 7, 2016, this recall, overseen by the National Medical Products Administration (NMPA), addresses a critical software anomaly. The main issue involves an inconsistency between the calculated dose and the machine hop count (Monitor Units or MU) when specific versions of the Eclipse system (11, 13, 13.5, or 13.6) use the Pencil Beam Convolution (PBC) Algorithm 11.0.31 for conventional arc field doses exceeding 100 subfields. Despite no reported incidents of improper radiation delivery to patients, the potential for inaccurate dose calculation led to this precautionary measure. Affected products are identified by NMPA Registration Certificate 20153700987. As immediate corrective actions, Varian has disseminated official documentation to all potentially impacted customers and is actively engaged in investigating and developing a permanent resolution for the software issue. This recall underscores Varian’s dedication to ensuring product safety and adherence to NMPA regulatory standards.