FDA recall Z-3162-2024

Btt Health Gmbh · Class II · device

Product

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

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).

Distribution

US Nationwide distribution in the states of Florida.

Key facts

Status
Ongoing
Initiation date
2024-08-01
Report date
2024-09-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Inning, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3162-2024