RegWardenFDA facility compliance records
Facility

MEDISTIM ASA

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

Activity by year

FDA actions on record by year2017: 1 recalls; 2025: 1 recalls120172018201920202021202220232024120252026
  • Recalls (2)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2025-09-26
    Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.
  • Class IITerminated2017-04-25
    A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.

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. “MEDISTIM ASA (FEI 3010790133) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010790133-medistim-asa/

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