Z-3162-2024Class II

Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment

Name: Z-3162-2024 Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Creator: Btt Health Gmbh
Published: 2024-08-01
License: https://open.fda.gov/license/

Btt Health GmbH / initiated 2024-08-01 / Open, Classified / root cause: design

FDA source

Btt Health Gmbh began a recall of Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment on 2024-08-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-3162-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-01
Posted: 2024-09-17
Recalling firm: Btt Health GmbH
Product: Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Product code: BXB Exerciser, Powered
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).
Root cause tag: design
FDA 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 in commerce: 62 units
Distribution: US Nationwide distribution in the states of Florida.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3162-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3162-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-17

Product code BXB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)