# China NMPA Product Recall - Eclipse Radiotherapy Planning System

Source: https://www.globalkeysolutions.net/records/china_product_recall/varian-medical-systems-inc/af700b82-c19e-49f7-a1f2-5ecdf65d1e45/
Source feed: China

> China NMPA product recall for Eclipse Radiotherapy Planning System by Varian Medical Systems, Inc. published June 18, 2010. Recall level: . Varian Medical Systems, Inc., through its Chinese subsidiary Varian Medical Devices Trading (Beijing

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Event Report Form for the Radiation Therapy Planning System (Eclipse)
- Company Name: Varian Medical Systems, Inc.
- Publication Date: 2010-06-18
- Product Name: Eclipse Radiotherapy Planning System
- Recall Reason: An anomaly was detected: when multiple users edit the same record simultaneously, the treatment plan record or treatment record may be corrupted, but the treatment record or treatment plan record will still be accessible.
- Manufacturing Company: Varian Medical Systems, Inc.
- Summary: Varian Medical Systems, Inc., through its Chinese subsidiary Varian Medical Devices Trading (Beijing) Co., Ltd., initiated a recall event for its Radiotherapy Planning System (Eclipse). This recall, reported to the National Medical Products Administration (NMPA) on June 18, 2010, addresses a critical software anomaly. The identified issue occurs when multiple users simultaneously edit the same record within the system, potentially corrupting the treatment plan or patient treatment records. Although the records remain accessible, their integrity may be compromised. Under the NMPA's regulatory oversight, Varian's required actions primarily involve informing affected users. The company's China Customer Support Center was tasked with distributing an "Emergency Notice on On-site Safety Matters" to relevant Chinese users, emphasizing the potential data damage and reminding them of precautions. Furthermore, Varian communicated an implementation plan and its completion status to these users. This recall pertains to 203 units of the Eclipse system globally, including those imported into China, highlighting the widespread impact of the software anomaly and the company's commitment to ensuring data reliability for radiotherapy planning.

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