FDA Device recall Z-0005-2019
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiothe…
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiothe… by Varian Medical Systems, citing 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 ga….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0005-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-20 |
| Published | 2018-10-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Varian Medical Systems |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | VitalBeam Version 2.5MR1 Systems (software 02.05.13.05/02.05.13.07): H192482 VITAL BEAM - 321274492 H192521 VITAL BEA…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0005-2019%22
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