Btt Health Gmbh: Device Recall
Recall #Z-3162-2024 · 08/01/2024
Class II: Risk
Recall Details
- Recall Number
- Z-3162-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Btt Health Gmbh
- Status
- Ongoing
- Date Initiated
- 08/01/2024
- Location
- Inning, Germany
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62 units
Reason for Recall
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 Description
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Distribution Pattern
US Nationwide distribution in the states of Florida.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.