FDA Medical Device Recalls (openFDA)
Btt Health Gmbh: Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
- Recall number
- Z-3162-2024
- Recalling firm
- Btt Health Gmbh
- Product
- Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
- Status
- Open, Classified
- Initiated
- 2024-08-01
- Posted
- 2024-09-17
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BXB
- Firm FEI
- 3013515165
- Firm city
- Inning
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28