FDA recall Z-1753-2025

Richard Wolf GmbH · Class II · device

Product

PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).

Reason for recall

The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.

Distribution

US State: GA

Key facts

Status
Ongoing
Initiation date
2025-04-09
Report date
2025-05-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Knittlingen, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1753-2025