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GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.
Device malfunction: causing electric shock and burn.
Devices have the potential to electric shock and burn
Labeling of patient position on scanned image does not match actual patient orientation.
Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.
The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009.
Possible overexposure: Failure to apply the entrance exposure rate (EER) tube current limit calibration to the automatic exposure rate (AER) control system when the anatomical profile mode is changed from the default selection to another selection. Manual technique modes are not affected.
GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner.
Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps