PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables t

FDA device recall Z-1753-2025 · posted 2025-05-13 · Open, Classified

Recall details

Recalling firm

Richard Wolf GmbH

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.

Action taken

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

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

ISA

Quantity affected

31 units

Distribution

US State: GA

Date initiated

2025-04-09

Date posted

2025-05-13

Location

Knittlingen, Germany