Drug recall
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and…
FDA recall event 81010 · Class II · Varian Medical Systems
Key facts
| Event ID | 81010 |
|---|---|
| Recall numbers | Z-0004-2019, Z-0005-2019 |
| Recalling firm | Varian Medical Systems |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 20, 2018 |
| Report date | Oct 10, 2018 |
| Termination date | Aug 28, 2020 |
| City | Palo Alto |
| State | CA |
| Country | United States |
| FEI number | 3006583922 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: