China NMPA Product Recall - Radiation Therapy Management software

Varian Medical Systems, Inc. has initiated a voluntary Class III recall of its Radiation Therapy Management software (Registration Certificate No.: 20152210146). This action, reported by Varian Medical Devices Trading (Beijing) Co., Ltd. to the National Medical Products Administration (NMPA) on April 12, 2022, addresses a significant operational issue. The primary concern involves mismatched treatment bed values that manifest during the software's use with specific models and batches of radiation therapy equipment. This critical malfunction has the potential to compromise the accuracy and safety of radiation therapy treatments. The manufacturer's decision to conduct a voluntary recall underscores its commitment to product integrity and patient well-being, under the oversight of the NMPA's regulatory framework. The recall requires affected parties to consult the "Medical Device Recall Event Report Form" for comprehensive details on specific product models and necessary actions to mitigate risks associated with the software defect.