# China NMPA Product Recall - Radiotherapy planning system

Source: https://www.globalkeysolutions.net/records/china_product_recall/varian-medical-systems-inc/1926b357-3e60-4bb2-bb15-9a024d2d8ef6/
Source feed: China

> China NMPA product recall for Radiotherapy planning system by Varian Medical Systems, Inc. published February 23, 2016. Recall level: Level 3. Varian Medical Systems, Inc., through its Chinese subsidiary Varian Medical Devices (China) Co., Ltd

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Varian Medical Systems, Inc. is voluntarily recalling its radiotherapy planning systems.
- Company Name: Varian Medical Systems, Inc.
- Publication Date: 2016-02-23
- Product Name: Radiotherapy planning system
- Recall Level: Level 3
- Recall Reason: When calculating conventional field doses with more than 100 subfields using Eclipse versions 11.13, 13.5, or 13.6 with PBC 11.0.31, the subfield doses do not match the calculated machine (MU), and Varian has not yet received any reports of issues leading to improper irradiation.
- Discovering Company: Varian Medical Equipment (China) Co., Ltd.
- Manufacturing Company: Varian Medical Systems, Inc.
- Summary: Varian Medical Systems, Inc., through its Chinese subsidiary Varian Medical Devices (China) Co., Ltd., initiated a global voluntary Class III recall of its Eclipse Radiotherapy Planning System, under the oversight of the National Medical Products Administration (NMPA). The recall, reported on January 20, 2016, and published on February 23, 2016, addresses a software inconsistency rather than an inspection finding; specific inspection dates were not provided.

The primary issue involves Eclipse software versions 11, 13, 13.5, and 13.6, specifically when utilizing the PBC 11.0.31 algorithm for calculating conventional arc field doses with more than 100 subfields. This combination may lead to an inconsistent machine output (Monitor Unit or MU) count for the dose. While Varian has not received any reports of actual patient harm or improper dose delivery directly attributed to this specific discrepancy, the potential for inaccurate dose calculation necessitated the recall. Older Eclipse versions, along with specific PBC algorithms and RapidArc/TrueBeam planning systems, remain unaffected.

As required by the NMPA's regulatory framework for medical devices (Registration No. 20153700987), Varian has communicated directly with all potentially affected customers, providing comprehensive documentation regarding the impacted product models and specifications. The company is actively developing a permanent solution to resolve the identified software issue.

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