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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

Btt Health Gmbh: Marodyne-LiV Low Intensity Vibration Exerciser Recalled for Treatment Interruptions

Agency Publication Date: September 17, 2024
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Summary

Btt Health Gmbh has recalled 62 units of the Marodyne-LiV Low Intensity Vibration Exerciser (part number 3045-133) used to support osteoporosis treatment. The recall was initiated because certain power supply units experience millisecond-long voltage drops, which cause the medical device to cancel the current treatment session and restart automatically. To continue therapy after this occurs, users must manually step off and back onto the device to reactivate it. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding this equipment issue.

Risk

A drop in voltage during use causes the device to stop treatment unexpectedly, which could lead to ineffective therapy or user frustration when the device requires manual reactivation. While the device restarts itself, the therapeutic session is canceled and will not resume unless the user performs a specific step-off and step-on sequence.

What You Should Do

  1. Check the serial number on the label of your Marodyne-LiV exerciser to see if it matches any of the 62 affected units. Affected serial numbers begin with 010426065891001421S or 010426065891000721S and include specific sequences such as 05327911240506 through 05329011240506, 05321911240430 through 05322611240430, and 05336411240521 through 05340511240521.
  2. Identify if your device frequently cancels treatment or requires you to step off and back on to restart a session, as this may indicate a faulty power supply unit.
  3. If your device is affected, contact your healthcare provider to discuss your treatment plan and ensure you are receiving the intended therapy.
  4. Contact Btt Health Gmbh at their headquarters in Germany at Billerberg 7, Inning, or reach out to your local distributor for technical support and potential power supply replacement.
  5. For additional questions or to report further issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Treatment reactivation required

How to: The treatment is restarted by a step-off/step-on (step-on for activation). Contact your healthcare provider or the manufacturer for further instructions and potential refund.

Affected Products

Product: Marodyne-LiV Low intensity vibration exerciser
Model / REF:
part number 3045-133
Lot Numbers (62):
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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95233
Status: Active
Manufacturer: Btt Health Gmbh
Manufactured In: Germany
Units Affected: 62 units
Distributed To: Florida

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.