Drug recall
GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a…
FDA recall event 83342 · Class II · Xcision Medical Systems, LLC
Key facts
| Event ID | 83342 |
|---|---|
| Recall numbers | Z-2081-2019 |
| Recalling firm | Xcision Medical Systems, LLC |
| Product type | Devices |
| Products | GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output. |
| Initiation date | Jul 3, 2019 |
| Report date | Jul 31, 2019 |
| Termination date | Jul 1, 2021 |
| City | Columbia |
| State | MD |
| Country | United States |
| FEI number | 3014273653 |
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: