Recall Z-0004-2019— Varian Medical Systems
Class II · Terminated
Class II FDA medical device recall by Varian Medical Systems, initiated 2018-08-20, terminated 2020-08-28. It names 2 FDA 510(k) clearances: K143224, K140528. 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..
- Recalling firm
- Varian Medical Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-20
- Terminated
- 2020-08-28
- Firm location
- Palo Alto, CA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.