PIEZOWAVE2 100506Recalls & reported problems
Richard Wolf GmbH · PIEZOWAVE 2 CONTROL UNIT for all standard indications in orthopedic extracorporeal shockwave therapy (ESWT) and trigger point shockwave therapy (TPST) as well as for acoustic compression therapy, touch screen, color display, control by footswitch, U: 100-240VAC, 50/60Hz, Dim. (wxhxd) 405x226x450mm · Class 1
All models of PIEZOWAVE2 (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207063989), received between Nov 12, 2024 and Nov 12, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Image Display Error/Artifact” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Image Display Error/Artifact1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2024Image Display Error/Artifact; Smoking; Image Display Error/Artifact; Smoking
ACCORDING TO THE INFORMATION RECEIVED, A FAULT MESSAGE AND SUBSEQUENT SMOKE DEVELOPMENT OCCURRED DURING AN APPLICATION OF THE PIEZOWAVE 2. THE PIEZOWAVE WAS DISCONNECTED FROM THE POWER SUPPLY. THE USER REPORTS THAT THERE WAS NO DANGER TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20667015 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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