FDA-Device2024-09-25Class II
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Btt Health Gmbh
Hazard
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).
Sold states
US Nationwide distribution in the states of Florida.
Affected count
62 units
Manufactured in
Billerberg 7, Inning, Germany
Products
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3162-2024Don't want to check this manually?
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