Class II — Btt Health Gmbh
| Recalling firm | BTT Health GmbH |
|---|---|
| Registered facility | BTT HEALTH GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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). |
| Product | Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment |
| Quantity | 62 units |
| Distribution | US Nationwide distribution in the states of Florida. |
| Initiated | 2024-08-01 |
| Classified | 2024-09-17 |
| Recall number | Z-3162-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Btt Health Gmbh (Z-3162-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95233/
Alerts for BTT Health GmbH
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.