
GE HealthCare · Model Unity Systems
GE HealthCare Unity Systems is classified as Patient Cables and Leadwires (Patient Monitoring). No manufacturer description has been sourced for this model yet.
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
No documents available for this device yet.
Synced live from the FDA openFDA API.
The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.
GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.
GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No injuries have been reported to date
Failure to properly pre-indicate the technique factors to be used during a patient scan.
The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
The Precision RXi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
GE Healthcare was notified that 2 recently installed Precision 500D systems were not in compliance with portions of the Performance Standard for Diagnostic X-ray Equipment. X-ray production was possible from the fluoroscopic X-ray tube when the Primary Protective Barrier was not in position to intercept the X-ray beam. Users are recommended to follow good clinical standards to ensure the Image I
Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury.
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