# China NMPA Product Recall - TrueBeam and TrueBeam STx Medical Linear Accelerators

Source: https://www.globalkeysolutions.net/records/china_product_recall/varian-medical-systems-inc/3fd3b41a-72ce-485f-8130-45e8c9bd8895/
Source feed: China

> China NMPA product recall for TrueBeam and TrueBeam STx Medical Linear Accelerators by Varian Medical Systems, Inc. published May 23, 2012. Recall level: . Varian Medical Systems, Inc. initiated a voluntary global recall of certain TrueBeam and TrueBeam ST

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Varian Medical Systems, Inc. is recalling TrueBeam and TrueBeam STx medical linear accelerators.
- Company Name: Varian Medical Systems, Inc.
- Publication Date: 2012-05-23
- Product Name: TrueBeam and TrueBeam STx Medical Linear Accelerators
- Recall Reason: When using the respiratory gating function of TrueBeam and TrueBeam STX, a gating protocol needs to be imported during the first treatment. An anomaly occurred when importing a gating protocol designated as "breath-hold" during CT simulation. This anomaly causes the "breath-hold" setting to be ignored during the gating protocol import. This itself does not cause the gating threshold to change, but the respiratory gating software is designed to discard imported gating thresholds when the gating technique (i.e., breath-hold, amplitude, or phase) settings are changed. Therefore, when the operator realizes that the parameters of the imported gating protocol are incorrect and selects the "breath-hold" option, the "breath-hold" gating threshold will be discarded. If the operator navigates forward or backward in the gating import wizard steps, the default gating threshold may also replace the planned threshold. A single step allows the selection of the default gating threshold when the gating technique has been changed; the default setting is not indicated during the gating import process.
- Discovering Company: Varian Medical Devices Trading (Beijing) Co., Ltd.
- Manufacturing Company: Varian Medical Systems, Inc.
- Summary: Varian Medical Systems, Inc. initiated a voluntary global recall of certain TrueBeam and TrueBeam STx medical linear accelerators, as detailed in a National Medical Products Administration (NMPA) publication on May 23, 2012. The recall, reported by Varian Medical Device Trading (Beijing) Co., Ltd. on May 15, 2012, addresses an anomaly found during CT simulation. The core issue arises when a "breath-hold" designated gating protocol is imported, causing the system to ignore this setting. If an operator subsequently attempts to manually select the "Break-Hold" option, the correct gating threshold may be discarded. Additionally, navigating the gating import wizard can inadvertently replace planned thresholds with unmarked default settings. The affected products include TrueBeam and TrueBeam STx, versions 1.0 to 1.5, though Varian confirmed no affected units were imported or sold in China. As a corrective measure, Varian will issue an Emergency Medical Device Calibration and Field Safety Notice to customers worldwide within three months. This notice will provide guidance on actions to avoid or mitigate these operational problems, ensuring proper device functionality and patient safety.

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