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Open, Classified

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

FDA Recall Z-3162-2024 · Posted 2024-09-17

Recalling FirmBtt Health Gmbh
Recall StatusOpen, Classified
Product CodeBXB
Date Initiated2024-08-01
Product Quantity62 units

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).

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

US Nationwide distribution in the states of Florida.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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