Facility

XCISION MEDICAL SYSTEMS, LLC

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3014273653
Establishment type	Manufacture Medical Device
Location	9176 RED BRANCH RD STE O Columbia, MD, US 21045
Registration status	Active · expires 2026
Parent company	Xcision Medical Systems (owner-operator 10056902)
Brand names	GammaPod Model A

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

System, Radiation Therapy, Radionuclide
Product code IWB (opens in a new tab) · Class II · Radiology · 21 CFR 892.5750

Recalls & enforcement

Class IIOngoing2023-11-30
Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
Class IITerminated2019-07-03
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.

FDA inspections (1)

NAI2020-01-09
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Xcision Medical Systems

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “XCISION MEDICAL SYSTEMS, LLC (FEI 3014273653) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014273653-xcision-medical-systems-llc/

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