PiezoWave 2 Control Unit therapeutic massager high voltage capacitor failure
Richard Wolf GmbH is recalling 31 PiezoWave 2 Control Units (Product Number 100506US) due to a high voltage capacitor that may fail early in the device's life cycle, potentially producing smoke, burning smell, spark, or excessive heat.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a device defect (capacitor failure) with potential for smoke, burning smell, spark, or heat; however, no injuries or illnesses have been reported in the source text, and the hazards described are moderate in nature rather than representing high-risk serious injury or death.
Plain-English summary
Richard Wolf GmbH is recalling the PiezoWave 2 Control Unit, Product Number 100506US, a compact myofascial acoustic compression therapy device used for piezoelectric shockwave treatment. The recall affects 31 units distributed in Georgia.
The high voltage capacitor in the device may fail early in the product's 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 failure may cause a spark or excessive heat.
Consumers who have received this device should stop use and contact Richard Wolf GmbH for further instructions regarding their unit. The specific serial numbers affected by this recall are listed by the FDA: 5000553232 through 5000553251, 5000553482 through 5000553486, 5000553488, and 5000553502 through 5000553506.
The recalled product
- Product
- PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
- Manufacturer
- Richard Wolf GmbH
- Hazard
- capacitor-failure
- fire
- burn-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00814334022863
Distribution
Distributed in 1 state:
- GA
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