RegWardenFDA facility compliance records
Company

BTT Health GmbH

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

Recalls by year

FDA actions on record by year2024: 1 recalls20172018201920202021202220231202420252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2024-08-01
    Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical device. The treatment is only restarted by a step-off/step-on (step-on for activation).

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. “BTT Health GmbH — 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-10054048-btt-health-gmbh/

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