# China NMPA Product Recall - Radiotherapy planning system

Source: https://www.keypedia.com/records/china_product_recall/varian-medical-systems-inc/fca33f5d-6fcb-4f0b-aea6-09a432ea951f
Source feed: China

> China NMPA product recall for Radiotherapy planning system by Varian Medical Systems, Inc. published July 07, 2016. Recall level: Level 3. Varian Medical Systems, Inc., in conjunction with its Chinese affiliate Varian Medical Devices (Chin

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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: 2016-07-07
- Product Name: Radiotherapy planning system
- Recall Level: Level 3
- Recall Reason: When calculating the dose for a conventional arc field with more than 100 subfields using PBC 11.0.31 in Eclipse versions 11, 13, 13.5, or 13.6, the indicated dose does not match the calculated machine hop count (MU). Varian has not received any reports of this issue resulting in improper irradiation.
- Discovering Company: Varian Medical Equipment (China) Co., Ltd.
- Manufacturing Company: Varian Medical Systems, Inc.
- Summary: 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.

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