PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
Enforcement
- Recall Number
- Z-1753-2025
- Event ID
- 96692
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Richard Wolf GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 21, 2025
- Initiation Date
- April 9, 2025
- Classification Date
- May 13, 2025
- Address
- Pforzheimer Str. 32, Knittlingen, N/A, Germany
Description
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
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.
UDI-DI: 00814334022863; Serial Numbers: 5000553232 5000553233 5000553234 5000553235 5000553236 5000553237 5000553238 5000553239 5000553240 5000553241 5000553242 5000553243 5000553244 5000553245 5000553246 5000553247 5000553248 5000553249 5000553250 5000553251 5000553482 5000553483 5000553484 5000553485 5000553486 5000553488 5000553502 5000553503 5000553504 5000553505 5000553506
US State: GA
31 units