Recall Z-1753-2025 ยท ISA Massager, Therapeutic, Electric
Richard Wolf GmbH
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
| Date | May 13, 2025 (initiated Apr 9, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device Recall notification letter dated 4/9/25 was sent to customers. Instructions to be taken by the distributor: Please read through both this letter and the attached Response Form. Please make sure that all users of the device are informed of this Urgent Medical Device Removal letter. Please follow the steps below: 1. Check your inventory/distribution reports for the device number and serial number(s) listed in the table above. 2. Without delay, remove the affected device from further distribution and/or use. 3. If you have distributed the device to a third party, please |
| Quantity | 31 units |
| Distribution | US State: GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.