ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
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Diagnostic Equipment
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ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
Class I - Dangerous
A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
Class I - Dangerous
Product is not approved or authorized for distribution in the US.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
Siemens Healthcare Diagnostics
Class I - Dangerous
Complaints of failed calibration.
When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
Siemens Healthcare Diagnostics
Class I - Dangerous
Complaints of failed calibration.
Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.
Class I - Dangerous
The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.
When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.