PiezoWave 2 therapeutic massagers recalled for capacitor failure hazard
Richard Wolf GmbH is recalling PiezoWave 2 control units because a high voltage capacitor may fail early in use, potentially producing smoke, burning smell, or in rare cases spark and excessive heat.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall addresses a risk-of-harm product where injury has not yet been reported. The capacitor defect creates a potential fire and burn hazard in a therapeutic device used on patients, with the hazard described as theoretical (extremely rare instances) and no actual incidents reported to date.
Plain-English summary
Richard Wolf GmbH is recalling 31 PiezoWave 2 Control Unit devices (Product Number 100506US) distributed in Georgia. The device is a therapeutic massager used for myofascial acoustic compression therapy with piezoelectric shockwaves.
The recall addresses a defect in the high voltage capacitor. The capacitor may fail early in the product's life cycle after exposure to surge voltages. When this occurs, the capacitor can produce smoke and a burning smell. In extremely rare instances, an internal capacitor failure may cause a spark or excessive heat.
Affected devices are identified by serial numbers ranging from 5000553232 to 5000553506 (with some gaps in sequence) and bear UDI-DI 00814334022863. No injuries or illnesses have been reported.
If you have one of these devices, discontinue use immediately and contact Richard Wolf GmbH.
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
- electrical-hazard
- 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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