Recall Z-3162-2024 ยท BXB Exerciser, Powered
Btt Health Gmbh
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
| Date | Sep 17, 2024 (initiated Aug 1, 2024) |
| Status | Open, Classified |
| 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). |
| Root cause | Component design/selection |
| 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. |
| Quantity | 62 units |
| Distribution | US Nationwide distribution in the states of Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.