System, X-ray, Mammographic

Hologic M-IV Mammography System; Model M4--00001.

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

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

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

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

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

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.

MammoTest Breast Biopsy System.

X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning.

Lorad M-IV Mammography System

System failed to meet the mA's accuracy specfications at low mA's values

Lorad MIV Platinum Mammograpgy System

System failed to meet the mA's accuracy specfications at low mA's values

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.

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.

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.