Drug recall
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning…
FDA recall event 86993 · Class II · Accuray Incorporated
Key facts
| Event ID | 86993 |
|---|---|
| Recall numbers | Z-0784-2021, Z-0785-2021 |
| Recalling firm | Accuray Incorporated |
| Product type | Devices |
| Products | TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic…, TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose. |
| Initiation date | Dec 10, 2020 |
| Report date | Jan 13, 2021 |
| Termination date | Sep 26, 2022 |
| City | Madison |
| State | WI |
| Country | United States |
| FEI number | 3003873069 |
At a glance
- 1–9 Products in this recall
- 1–9 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: