RegWardenFDA facility compliance records
Facility

XSTRAHL LIMITED

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

Activity by year

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

Devices registered here (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.

Related

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. “XSTRAHL LIMITED (FEI 3004561814) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004561814-xstrahl-limited/

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