There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Leakage in Cepheid SmartCycler reaction tubes.
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Leakage in Cepheid SmartCycler reaction tubes.
Leakage in Cepheid SmartCycler reaction tubes.
Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
Toshiba American Medical Systems
Class I - Dangerous
The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil.
The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the unusual case of preventing the optimizatio
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Class I - Dangerous
When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expecte
Leakage in Cepheid SmartCycler reaction tubes.
Class I - Dangerous
Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error messages (instrument errors), which indicate calibration failures.
Software anomaly may result in incorrect values and interpretations. The initial vital signs reading will display accurately on the Cisco Health Presence Vitals tab and the OnePlace tab. However, subsequent vital signs readings will only update on the Cisco HealthPresence Vitals tab and within the OnePlace database, but will not update under the OnePlace tab, and thus, will not provide current vit
Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount
Class I - Dangerous
Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results.
EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
Toshiba American Medical Systems
Class I - Dangerous
The status display in the sequence queue window may not change from "Current" to "Done".
The systems all have a similar table control board. It has been found that this board may cause the table position to be incorrect if the table cradle is moved manually. This is referred to as "Free" mode in the operation manuals. If this error does occur it is possible that the patient could be scanned at an incorrect position.
Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed between September 31, 2010 and January 9, 2012.
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
Toshiba American Medical Systems
Class I - Dangerous
1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco
syngo Imaging XS. Radiological image processing system.
Siemens Medical Solutions USA
Class I - Dangerous
There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".