System, X-Ray, Mammographic
FDA adverse event reports and recall history for system, x-ray, mammographic (product code IZH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 439
- Deaths
- 0
- Injuries
- 105
- Malfunctions
- 271
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2014-06-03TerminatedComponent change control
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
- 2008-09-26TerminatedRadiation Control for Health and Safety Act
GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senographe DS Stereotaxy is an optional accessory for the Senographe system for mammography examinations.
GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use of the Stereotactic Positioner of your Senographe DS Acquisition system and could impact patient safety. If the Stereotactic Positioner is removed when the examination arm is at 33 degrees and, th
- 2008-09-26TerminatedRadiation Control for Health and Safety Act
GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senographe DS Stereotaxy is an optional accessory for the Senographe system for mammography examinations.
GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use of the Stereotactic Positioner of your Senographe DS Acquisition system and could impact patient safety. If the Stereotactic Positioner is removed when the examination arm is at 33 degrees and, th
- 2007-06-28TerminatedOther
Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
GE Healthcare has become aware of the absence of thread-locking compound associated with the C-arm fasteners of your Diamond mammographic x-ray system that may impact patient safety.
- 2005-01-05TerminatedOther
MammoTest Breast Biopsy System.
X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning.
- 2004-08-11TerminatedOther
Lorad M-IV Mammography System
System failed to meet the mA's accuracy specfications at low mA's values
- 2004-08-11TerminatedOther
Lorad MIV Platinum Mammograpgy System
System failed to meet the mA's accuracy specfications at low mA's values
- 2004-07-20TerminatedOther
Seneographe 2000D Digital Mammography X-Ray System
The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.
- 2004-07-20TerminatedOther
Seneographe DMR Mammography X-Ray System (all versions)
The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.
- 2004-07-20TerminatedOther
Seneographe 700T Mammography X-Ray Systems
The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.
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