Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
🔬
Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Potential of an allergic reaction in a patient with nickel sensitivity.
Class I - Dangerous
The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Neusoft Medical Systems Co.
Class I - Dangerous
It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options.
Class I - Dangerous
The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Class I - Dangerous
The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Class I - Dangerous
MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.
Siemens Medical Solutions USA
Class I - Dangerous
The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet.
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
Siemens Medical Solutions USA
Class I - Dangerous
While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-mode cursor, the 2D field of view, or the RES region of interest with the trackball.