NA 72200873SRRecalls & reported problems
Smith & Nephew, Inc. · DYONICS POWER II SHAVER SYSTEM CONTROL UNIT. ALL UNITS 100-240 VAC, 50/60 HZ SERVICE REPLACEMENT · 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 00885556624197), received between Jan 3, 2018 and Oct 15, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (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
- Device Displays Incorrect Message1
- Electrical Shorting1
- Overheating of Device1
- Smoking1
Patient problems
- No Patient Involvement2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MOTOR DRIVE UNIT OVERHEATED. 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 Patient Involvement
MAUDE report 10687171 ↗MalfunctionMay 21, 2018Device Displays Incorrect Message
IT WAS REPORTED THAT BOX WAS SHOWING AN ERROR FOR ANY HAND PIECE PLACED IN THE PORTS: SHORT CIRCUIT. UNIT SMELLED LIKE BURNT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7530732 ↗MalfunctionJan 3, 2018Smoking; Electrical Shorting
IT WAS REPORTED BY CUSTOMER THAT DEVICE PRESENTED A SHORT CIRCUIT WITH THE SMELL OF SMOKE, BEFORE THE CASE AND NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7162822 ↗
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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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