Recall Z-3162-2024— Btt Health Gmbh
Class II · Ongoing
Class II FDA medical device recall by Btt Health Gmbh, initiated 2024-08-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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)..
- Recalling firm
- Btt Health Gmbh
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-01
- Firm location
- Inning, Germany
Product description
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.