Recall Z-1753-2025— Richard Wolf GmbH
Class II · Ongoing
Class II FDA medical device recall by Richard Wolf GmbH, initiated 2025-04-09. FDA's recall record names no specific 510(k) clearance for this event. Product: PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).. Reason: 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..
- Recalling firm
- Richard Wolf GmbH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-09
- Firm location
- Knittlingen, Germany
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.