Unit, X-Ray, Intraoral
FDA adverse event reports and recall history for unit, x-ray, intraoral (product code EAP), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 545
- Deaths
- 0
- Injuries
- 8
- Malfunctions
- 453
Reports per year
Source: FDA adverse event reports by year received, 2002–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2013-05-21TerminatedRadiation Control for Health and Safety Act
Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Also, the user's manual was found to have missing or improperly labeled information as required by 21 CFR 1020.30(h).
- 2013-05-02TerminatedRadiation Control for Health and Safety Act
CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
- 2013-05-02TerminatedRadiation Control for Health and Safety Act
CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
- 2013-05-02TerminatedRadiation Control for Health and Safety Act
CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
- 2013-05-02TerminatedRadiation Control for Health and Safety Act
CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.
- 2013-04-17TerminatedRadiation Control for Health and Safety Act
DeGotzen XRay unit XGenus Dental X-ray unit.
It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification
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