Drug recall
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance…
FDA recall event 82384 · Class II · Elekta Limited
Key facts
| Event ID | 82384 |
|---|---|
| Recall numbers | Z-1109-2019 |
| Recalling firm | Elekta Limited |
| Product type | Devices |
| Products | Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the… |
| Initiation date | Mar 12, 2019 |
| Report date | Apr 17, 2019 |
| Termination date | Nov 3, 2023 |
| City | Crawley |
| Country | United Kingdom |
| FEI number | 3002806900 |
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: