Inning, Germany
Btt Health Gmbh recalls
1 recall recorded since 2018, most recently on 1 August 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 August 2024
- 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).
- Distribution
- US Nationwide distribution in the states of Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3162-2024
- Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.