Drug recall
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120…
FDA recall event 85269 · Class II · Varian Medical Systems, Inc.
Key facts
| Event ID | 85269 |
|---|---|
| Recall numbers | Z-1899-2020 |
| Recalling firm | Varian Medical Systems, Inc. |
| Product type | Devices |
| Products | Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient… |
| Initiation date | Aug 12, 2019 |
| Report date | May 13, 2020 |
| Termination date | Jan 21, 2021 |
| City | Palo Alto |
| State | CA |
| Country | United States |
| FEI number | 2916710 |
At a glance
- 1–9 Products in this recall
- 10–99 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: