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

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.