FDA Device recall Z-0004-2019
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam…
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam… 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-0004-2019 |
| 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
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide 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 | TrueBeam version 2.0 Systems (software 02.00.33.02): H191007 TRUEBEAM H191017 TRUEBEAM H191024 TRUEBEAM H191025 TRU…TrueBeam version 2.0 Systems (software 02.00.33.02): H191007 TRUEBEAM H191017 TRUEBEAM H191024 TRUEBEAM H191025 TRUEBEAM - SO# 320239788 H191084 TRUEBEAM H191100 TRUEBEAM - SO# 320350217 H191131 TRUEBEAM H191181 TRUEBEAM - SO# 320394400 H191204 TRUEBEAM H191207 TRUEBEAM H191265 TRUEBEAM H191266 TRUEBEAM - 320442198 H191296 TRUEBEAM H191326 TRUEBEAM - 320649017 H191335 TRUEBEAM - SO# 320534442 H191349 TRUEBEAM - 320614871 H191369 TRUEBEAM - SO# 320470280 H191385 TRUEBEAM - 320612175 H191396 TRUEBEAM H191397 TRUEBEAM H191419 TRUEBEAM H191423 TRUEBEAM H191442 TRUEBEAM H191457 TRUEBEAM H191465 TRUEBEAM - SO# 320740369 H191477 TRUEBEAM H191491 TRUEBEAM - SO# 320684489 H191537 TRUEBEAM H191564 TRUEBEAM - SO# 320816541 H191613 TRUEBEAM H191616 TRUEBEAM H191623 TRUEBEAM H191627 TRUEBEAM H191642 TRUEBEAM H191647 TRUEBEAM H191654 TRUEBEAM H191670 TRUEBEAM H191676 TRUEBEAM - SO# 320886799 H191682 TRUEBEAM - 320816854 H191685 TRUEBEAM - SO# 320938575 H19169 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0004-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.