FDA Recall
Open, Classified
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Recall: Z-3162-2024
·
Initiated August 1, 2024
Recall
- Recall Number
- Z-3162-2024
- Event Number
- 95233
- Firm
- Btt Health Gmbh Billerberg 7 Inning Germany
- FEI Number
- 3013515165
- Product Code
- BXB
- Status
- Open, Classified
- Root Cause
- Component design/selection
- Initiated
- August 1, 2024
- Posted
- September 17, 2024
Description
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
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).
Action
Btt notified its distributors on 08/01/2024 via email. The notice explained the problem with the device, impact the the user, and were directed to notify their customers. The power supplies will be replaced.
Distribution
US Nationwide distribution in the states of Florida.
Quantity
62 units