Btt Health Gmbh recalls Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment

Recall date

August 1, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3162-2024

FDA classification

Class II

Brand / firm

Btt Health Gmbh

Sold / distributed

US Nationwide distribution in the states of Florida.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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