medical Class II Updated 2018-10-10

Varian Medical Systems recalls VitalBeam Radiotherapy Delivery System Version 2.5 Produc

Recalled Product

VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Hazard / Issue

Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: VitalBeam Version 2.5MR1 Systems (software 02.05.13.05/02.05.13.07): H192482 VITAL BEAM - 321274492 H192521 VITAL BEAM H192743 VITAL BEAM H192816 VITAL BEAM Varian Product Code family H19, which includes TrueBeam, TrueBeam STx, VitalBeam and EDGE.

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