Xios XG Supreme 6778240Recalls & reported problems
Dentsply International Inc. · XIOS XG SUPREME/AE USB S2 SNSR KIT 270CM · Class 2
Data updated Oct 18, 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 D00367782401), received between Feb 24, 2026 and Feb 24, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Poor Quality Image” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image1
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.
MalfunctionFeb 24, 2026Poor Quality Image
WHILE THE CUSTOMER WAS USING A PART OF AN INTRAORAL SENSOR SYSTEM, XIOS XG SUPREME AE USB S2 SENSOR,270CM, THEY ALLEGE THE DEVICE SELF TRIGGERED, CAUSING AN X-RAY IMAGE TO BE TAKEN WITHOUT PROMPTING THE DEVICE TO TAKE AN IMAGE. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429756 ↗
Other Solid state x-ray imager (flat panel/digital imager) devices
- SEDECAL SM-40HF-B-D-CSedecal · Solid State X-Ray Imager (Flat Panel/Digital Imager)24 recalls1 report
- SEDECAL SM-40HF-B-D-VIRSedecal · Solid State X-Ray Imager (Flat Panel/Digital Imager)12 recalls1 report
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)7 recalls0 reports
- DigitalDiagnost C90 712034Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)3 recalls90 reports
- DigitalDiagnost C90 712035Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)4 recalls17 reports
- DigitalDiagnost 712031Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)2 recalls65 reports
- NA GM85Samsung Electronics Co., Ltd. · Solid State X-Ray Imager (Flat Panel/Digital Imager)3 recalls4 reports
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)3 recalls0 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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