Z-1753-2025Class II

PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device...

Name: Z-1753-2025 PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device...
Creator: Richard Wolf GmbH
Published: 2025-04-09
License: https://open.fda.gov/license/

Richard Wolf GmbH / initiated 2025-04-09 / Open, Classified / root cause: manufacturing process

FDA source

Richard Wolf GmbH began a recall of PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves... on 2025-04-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1753-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-09
Posted: 2025-05-13
Recalling firm: Richard Wolf GmbH
Product: PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
Product code: ISA Massager, Therapeutic, Electric
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.
Root cause tag: manufacturing process
FDA 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 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 [email protected] 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1753-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1753-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-13

Product code ISA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)