Drug recall
Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation…
FDA recall event 82537 · Class II · Elekta Limited
Key facts
| Event ID | 82537 |
|---|---|
| Recall numbers | Z-1297-2019 |
| Recalling firm | Elekta Limited |
| Product type | Devices |
| Products | Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated. |
| Initiation date | Apr 3, 2019 |
| Report date | May 15, 2019 |
| Termination date | May 1, 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: