PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables t
Summary
The FDA issued a Class II for PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic c by Richard Wolf GmbH. 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 prod.
Details
Source
Device Recall
External ID
Z-1753-2025
Action Date
2025-05-21
Status
Ongoing
Category
device
Product Description
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
Lot/Code Info: 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
Quantity Affected: 31 units
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.
Distribution
US State: GA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-09
Company
Knittlingen
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Richard Wolf GmbH has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Richard Wolf GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Richard Wolf GmbH have FDA actions?
Richard Wolf GmbH has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1753-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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