Drug recall
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic…
FDA recall event 73761 · Class II · Elekta, Inc.
Key facts
| Event ID | 73761 |
|---|---|
| Recall numbers | Z-1561-2016 |
| Recalling firm | Elekta, Inc. |
| Product type | Devices |
| Products | Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame. |
| Initiation date | Apr 19, 2016 |
| Report date | May 4, 2016 |
| Termination date | Jul 16, 2021 |
| City | Atlanta |
| State | GA |
| Country | United States |
| FEI number | 1037831 |
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: