Class 2 Device Recall PiezoWave2

• Date Initiated by Firm: April 09, 2025
• Date Posted: May 13, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1753-2025
• Recall Event ID: 96692
• Product Classification: Massager, therapeutic, electric - Product Code ISA
• Product: PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
• Code Information: 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
• Recalling Firm/ Manufacturer: Richard Wolf GmbH; Pforzheimer Str. 32; Knittlingen Germany
• For Additional Information Contact: Michael J McAndrew; 847-913-1113
• Manufacturer 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.
• FDA Determined 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 notify your customer of the recall and instruct them to remove the affected device from use. If you wish to provide your customers with an separate notification letter, RW GmbH must review and approve the letter prior to sending it to your customers. 4. To verify that you have received this Urgent Medical Device Removal letter, return the enclosed Response Form by 04-25-2025; indicate device serial number you have in your control and send this response form to us via e-mail to FSCA700023919@richard-wolf.com Please complete this form even if you no longer have the device in stock. In doing so, you will be confirming receipt of this Urgent Medical Device Removal letter, and you will not receive any further reminders from Richard Wolf. 5. After we receive your Response Form, Richard Wolf will coordinate with you on providing high voltage PCB with non-defective capacitors as replacements. 6. Provide this letter or your customer notification letter described in Step 2 above to each of your customers 7. Replace PCB, record and send form to RWMIC. Each PCB with the defective capacitors shall be returned to Richard Wolf Medical Instruments Corporation. 8. Complete the Tracking form provided and return the form and PCB with defective capacitors to Richard Wolf Medical Instruments Corporation upon completion of the recall activity. 9. Provide monthly updates to Richard Wolf Medical Instr
• Quantity in Commerce: 31 units
• Distribution: US State: GA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.