Medical equipment, implants, and diagnostic devices
Terumo Cardiovascular Systems
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
The temperature probe does not properly connect to the temperature port.
Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functions Region of Interest , Pixel Lens , Edge enhancement and Histograms . This potential malfunction may occur for images with a pixel depth greater than 12 bit. All values calculated for images with a pixel d
M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory settings. The controller during different settings such as max forward speed, max forward acceleration, max reverse speed and max turning speed can result in momentary loss of control.
Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product.
Terumo Cardiovascular Systems
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low CO2 values.
The temperature probe does not properly connect to the temperature port.
The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
The femoral stem is lacking specified plasma coating.
Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)
Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.