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Btt Health Gmbh recalls Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Recalled September 25, 2024 · FDA recall Z-3162-2024 · Btt Health
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). · FDA Class II
Units
62 units
Sold at
US Nationwide distribution in the states of Florida.
Description
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).
Product
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Manufacturer(s)
Btt Health Gmbh
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →