MAUDE manufacturer profile
ELEKTA INSTRUMENT AB · IWB
MAUDE profile for System, Radiation Therapy, Radionuclide
Key facts
| Manufacturer | ELEKTA INSTRUMENT AB |
|---|---|
| Manufacturer group | ELEKTA INSTRUMENT AB |
| Product code | IWB |
| Product code name | System, Radiation Therapy, Radionuclide |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, No Known Impact Or Consequence To Patient, Computer Software Problem, Device Operates Differently Than Expected, Misassembled, Adverse Event Without Identified Device or Use Problem, Electrical /Electronic Property Problem, Break Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1