NA 72200873S3ERecalls & reported problems
Smith & Nephew, Inc. · DYONICS POWER II SHAVER SYSTEM CONTROL UNIT. ALL UNITS 100-240 VAC, 50/60 HZ SERVICE THIRD EDITION · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885554030815), received between Apr 26, 2018 and Dec 23, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission 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
- Communication or Transmission Problem1
- Crack1
- Device Displays Incorrect Message1
- Electrical /Electronic Property Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2020Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE DYONICS POWER II HAD A BAD CONNECTION TO THE HAND PIECE AND COULD NOT BE RECOGNIZED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11064816 ↗MalfunctionMay 17, 2018Electrical /Electronic Property Problem; Device Displays Incorrect Message
IT WAS REPORTED THAT THE CONTROLLER PRESENTED A WARNING ERROR FOR SHORT CIRCUIT. NO PATIENT INJURY OR SIGNIFICANT TIME DELAY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7521870 ↗MalfunctionApr 26, 2018Crack
IT WAS REPORTED THAT THE INPUT METAL COVERING SHIELD IS CHIPPED. NO BACK UP WAS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7467140 ↗
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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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