RegWardenFDA facility compliance records
Company

Xcision Medical Systems

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

Recalls by year

FDA actions on record by year2019: 1 recalls; 2023: 1 recalls201720181201920202021202212023202420252026
  • Recalls (2)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Xcision Medical Systems — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10056902-xcision-medical-systems/

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