# China NMPA Product Recall - Radiation Therapy Management software

Source: https://www.globalkeysolutions.net/records/china_product_recall/varian-medical-systems-inc/ae735198-1524-4999-a61a-06dc9f81d216/
Source feed: China

> China NMPA product recall for Radiation Therapy Management software by Varian Medical Systems, Inc. published April 12, 2022. Recall level: Level 3 Recall. Varian Medical Systems, Inc. has initiated a voluntary Class III recall of its Radiation Therapy Man

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Varian Medical Systems, Inc. has initiated a voluntary recall of its Radiation Therapy Management software.
- Company Name: Varian Medical Systems, Inc.
- Publication Date: 2022-04-12
- Product Name: Radiation Therapy Management software
- Recall Level: Level 3 Recall
- Recall Reason: Problem of mismatch in treatment bed values during software operation
- Discovering Company: Varian Medical Devices Trading (Beijing) Co., Ltd.
- Manufacturing Company: Varian Medical Systems, Inc.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/varian-medical-systems-inc/ecd1e48f-3c7e-48c1-a3d3-a4c6add7e12d/