D-ACTOR® 100Recalls & reported problems
Storz Medical AG · Pulse Activation Therapy System · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630039101060), received between Dec 3, 2021 and Dec 3, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Tinnitus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2021Use of Device Problem; Use of Device Problem
DURING A DEVICE DEMONSTRATION, A SALES REPRESENTATIVE WAS TREATING A VOLUNTEER (A "MOCK PATIENT" WITHOUT PRE-EXISTING NECK PROBLEMS) NEXT TO THE CERVICAL SPINE (HEIGHT C3-C4) WITH THE RADIAL SHOCKWAVE DEVICE D-ACTOR 100 WITH SPINE APPLICATOR TIP 3 AT 2.0 BAR WITH 2000 SHOTS. D-ACTOR IS A DEVICE FOR PRESCRIPTION USE ONLY UNDER (21 CFR 801 SUBPART D), I.E., FOR USE ONLY BY A LICENSED PRACTITIONER (I.E. IFU INTENDED EXCLUSIVELY FOR USE BY HEALTH CARE PROFESSIONAL). THE SALES REPRESENTATIVE IS NOT A LICENSED PRACTITIONER, NOR A HEALTH CARE PROFESSIONAL, SO HE SHOULD NOT HAVE USED THE DEVICE ON HUMANS. THE VOLUNTEER WAS NOT OFFERED EAR PROTECTION AS RECOMMENDED IN THE IFU. IT HAS ALSO BEEN REPORTED THAT EVEN THOUGH THE VOLUNTEER`S TEETH WERE CHATTERING DURING TREATMENT, SHE HAS NOT BEEN ASKED FOR FEEDBACK REGARDING TREATMENT INTENSITY OR PAIN / DISCOMFORT. APPARENTLY, THE CHOSEN ENERGY LEVEL / PATIENT POSITIONING WAS NOT APPROPRIATE FOR THAT PARTICULAR PATIENT. AS PER IFU, TREATMENT SHOULD ALWAYS START AT A LOW ENERGY LEVEL THAT SHOULD BE INCREASED GRADUALLY DURING TREATMENT. FURTHERMORE, TREATMENT WAS APPLIED TO THE SPINAL COLUMN AND/OR VERTEBRAE AND THE IFU ASKS USERS TO TAKE CAUTION
Patient problems: Tinnitus
MAUDE report 12927541 ↗
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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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