X-Smart Pro 6779016Recalls & reported problems
SIRONA Dental Systems GmbH · X-Smart Pro+ · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI E27667790160), received between Sep 19, 2025 and Dec 19, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (3 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement3
- Explosion1
- Fire1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT WAS REPORTED THAT A VDW GOLD RECIPROC GAVE INCORRECT MEASUREMENTS; NO PATIENT INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857857 ↗MalfunctionDec 19, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT WAS REPORTED THAT THE APEX LOCATOR OF A VDW.GOLD RECIPROC DOES NOT WORK ( NO SOUND/NO VISUAL SIGN ) WHEN IT COMES TO THE APEX LENGTH. OUTCOME OF PATIENT INJURY IS PENDING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23857838 ↗MalfunctionDec 19, 2025Incorrect Measurement; Incorrect Measurement
IN THIS EVENT IT IS REPORTED THAT VDW.GOLD RECIPROC GIVING INCORRECT MEASUREMENTS WITH THE APEX LOCATOR. CUSTOMER HAVING PROBLEM WITH THE APEX LOCATOR, EVEN AFTER CHANGING MOUTH WIRE. ERROR STILL READS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23854329 ↗MalfunctionSep 19, 2025Fire; Explosion; Fire; Explosion
IT WAS REPORTED THAT THE POWER SUPPLY CHARGER FOR AN X-SMART PRO + DEVICE CAUGHT FIRE AND BURST. NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096746 ↗
Other Locator, root apex devices
- PROMARK APEX LOCATOR V841113000000VDW GmbH · Locator, root apex106 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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