XCISION MEDICAL SYSTEMS, LLC — FDA Facility Profile
XCISION MEDICAL SYSTEMS, LLC is an FDA-registered facility (FEI 3014273653) located in Columbia, MD, US. RegDataLab tracks 1 FDA inspection at this facility.
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What FDA found at this site
- Latest inspection
- Jan 9, 2020: No Action Indicated (NAI)
- Inspections on record
- 1 (1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 2, latest Nov 30, 2023
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jan 9, 2020 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Nov 30, 2023 | Not yet classified | Z-0750-2024 | GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System… Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be… |
| Jul 3, 2019 | Not yet classified | Z-2081-2019 | GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02
Product… One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output. |
Facility details
- Company
- Xcision Medical Systems, LLC
- Location
- Columbia, MD (US)
- Source
- device