RegWardenFDA facility compliance records
Company

XSTRAHL LIMITED

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

Recalls by year

FDA actions on record by year2021: 2 recalls; 2022: 1 recalls201720182019202022021120222023202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2022-04-27
    There is a potential compatibility issue with the systems and replacement treatment applicators.
  • Class IITerminated2021-08-27
    Base plate may detach from the main body of the treatment applicator.
  • Class IITerminated2021-04-26
    If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible mis-treatment.

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. “XSTRAHL LIMITED — 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-9026784-xstrahl-limited/

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