FDA Adverse Event
Malfunction
Summary report: N
LEKSELL VANTAGE STEREOTACTIC SYSTEM
MDR report key: 23615856
·
Received November 21, 2025
Report
- Report Number
- 3015232217-2025-00072
- Event Type
- Malfunction
- Date Received
- November 21, 2025
- Report Date
- May 14, 2026
- Manufacturer
- ELEKTA SOLUTIONS AB
- Product Code
- HAW
- UDI-DI
- 07340048304399
- PMA / PMN Number
- K190887
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.
Description of Event or Problem · 0
THE CUSTOMER REPORTED THAT DURING THE PROCEDURE THE PLANNED POSITION WAS OUT OF SCOPE ABOUT 3MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 552626 | LEKSELL VANTAGE STEREOTACTIC SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | ELEKTA SOLUTIONS AB | 07340048304399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |