Marodyne-LiV vibration exerciser recalled for power supply voltage defect
Marodyne-LiV low-intensity vibration exercisers with certain serial numbers are recalled due to a power supply voltage drop that unexpectedly interrupts treatment. Manual activation is required to restart the device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device recall with no reported injuries or illnesses. The hazard is a functional power supply defect causing treatment interruption, which does not constitute direct patient harm or high-risk contamination.
Plain-English summary
Marodyne-LiV, part number 3045-133, is a low-intensity vibration exerciser designed to support osteoporosis treatment. This recall affects 62 units bearing specific serial numbers.
Power supply units in certain affected devices experience a brief voltage drop in the millisecond range. This voltage drop causes the osteoporosis treatment to stop unexpectedly and requires manual activation (step-on) to restart the device.
The issue has been identified in power supply units located in Austria and Germany.
The recalled product
- Product
- Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
- Manufacturer
- Btt Health Gmbh
- Affected units
- 62
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- serial numbers: 010426065891001421S05327911240506
- 010426065891001421S05328011240506
- 010426065891001421S05328111240506
- 010426065891001421S05328211240506
- 010426065891001421S05328311240506
- 010426065891001421S05328411240506
- 010426065891001421S05328511240506
- 010426065891001421S05328611240506
- 010426065891001421S05328711240506
- 010426065891001421S05328811240506
- 010426065891001421S05328911240506
- 010426065891001421S05329011240506
- 010426065891001421S05321911240430
- 010426065891001421S05322011240430
- 010426065891001421S05322111240430
- 010426065891001421S05322211240430
- 010426065891001421S05322311240430
- 010426065891001421S05322411240430
- 010426065891001421S05322511240430
- 010426065891001421S05322611240430
Distribution
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