# China NMPA Product Recall - Radiotherapy planning system

Source: https://www.globalkeysolutions.net/records/china_product_recall/varian-medical-systems-inc/44edfc81-31d2-47bf-91a0-43cf15b5ab9c/
Source feed: China

> China NMPA product recall for Radiotherapy planning system by Varian Medical Systems, Inc. published April 10, 2012. Recall level: . Varian Medical Systems, Inc., through its Chinese subsidiary, Varian Medical Devices Trading (Beijin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Varian Medical Systems, Inc. is recalling its radiotherapy planning systems.
- Company Name: Varian Medical Systems, Inc.
- Publication Date: 2012-04-10
- Product Name: Radiotherapy planning system
- Recall Reason: Intermittent pixel offset error within the 3D volume created in Eclipse SRS Localization
- Discovering Company: Varian Medical Devices Trading (Beijing) Co., Ltd.
- Manufacturing Company: Varian Medical Systems, Inc.
- Summary: Varian Medical Systems, Inc., through its Chinese subsidiary, Varian Medical Devices Trading (Beijing) Co., Ltd., initiated a voluntary global recall of certain radiotherapy planning systems on March 27, 2012, as reported by the National Medical Products Administration (NMPA) on April 10, 2012. The recall, documented under NMPA Index No. JGXX-2012-10041 and involving products with CFDA Import Registration No. 20083322191, was prompted by an intermittent pixel offset error within the stereotactic volume of its Eclipse SRS Localization feature. This critical product defect could potentially impact treatment accuracy. As a corrective measure, Varian committed to distributing a customer technical bulletin and providing instructions to mitigate the issue to affected users worldwide within three months. While this recall had a global scope, Varian stated that it did not involve the Chinese market, reporting zero sets imported or sold in China. The NMPA, operating under its medical device regulatory framework, urged regional food and drug administrations to enhance oversight of such medical devices.

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