RegWardenFDA facility compliance records
Company

Swissray Medical AG

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

Recalls by year

FDA actions on record by year2016: 2 recalls; 2018: 1 recalls2201620171201820192020202120222023202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2018-11-14
    A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column, which is designed to take the load, can break without triggering the safety lock. This can lead to over…
  • Class IIOngoing2016-11-18
    Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
  • Class IIOngoing2016-08-09
    Possible injury due to movement of the arm, calibration loss and communication loss.

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. “Swissray Medical AG — 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-9003721-swissray-medical-ag/

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