Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Enforcement
- Recall Number
- Z-3162-2024
- Event ID
- 95233
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Btt Health Gmbh
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- September 25, 2024
- Initiation Date
- August 1, 2024
- Classification Date
- September 17, 2024
- Address
- Billerberg 7, Inning, N/A, Germany
Description
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
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).
serial numbers: 010426065891001421S05327911240506, 010426065891001421S05328011240506, 010426065891001421S05328111240506, 010426065891001421S05328211240506, 010426065891001421S05328311240506, 010426065891001421S05328411240506, 010426065891001421S05328511240506, 010426065891001421S05328611240506, 010426065891001421S05328711240506, 010426065891001421S05328811240506, 010426065891001421S05328911240506, 010426065891001421S05329011240506, 010426065891001421S05321911240430, 010426065891001421S05322011240430, 010426065891001421S05322111240430, 010426065891001421S05322211240430, 010426065891001421S05322311240430, 010426065891001421S05322411240430, 010426065891001421S05322511240430, 010426065891001421S05322611240430, 010426065891000721S05336411240521, 010426065891000721S05336511240521, 010426065891000721S05336611240521, 010426065891000721S05336711240521, 010426065891000721S05336811240521, 010426065891000721S05336911240521, 010426065891000721S05337011240521, 010426065891000721S05337111240521, 010426065891000721S05337211240521, 010426065891000721S05337311240521, 010426065891000721S05337411240521, 010426065891000721S05337511240521, 010426065891000721S05337611240521, 010426065891000721S05337711240521, 010426065891000721S05337811240521, 010426065891000721S05337911240521, 010426065891000721S05338011240521, 010426065891000721S05338111240521, 010426065891000721S05338211240521, 010426065891000721S05338311240521, 010426065891000721S05338411240521, 010426065891000721S05338511240521, 010426065891000721S05338611240521, 010426065891000721S05338711240521, 010426065891000721S05338811240521, 010426065891000721S05338911240521, 010426065891000721S05339011240521, 010426065891000721S05339111240521, 010426065891000721S05339211240521, 010426065891000721S05339311240521, 010426065891000721S05339411240521, 010426065891000721S05339511240521, 010426065891000721S05339611240521, 010426065891000721S05339711240521, 010426065891000721S05339811240521, 010426065891000721S05339911240521, 010426065891000721S05340011240521, 010426065891000721S05340111240521, 010426065891000721S05340211240521, 010426065891000721S05340311240521, 010426065891000721S05340411240521, 010426065891000721S05340511240521
US Nationwide distribution in the states of Florida.
62 units