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Nonconformance to performance specifications.
The device may disarm and not deliver shock when performing a Synchronized Cardioversion
Does not meet performance claims in the labeling.
Potential for deployment difficulties.
Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient.
Excessive heating due to incorrect wire assembly process.
When ISOLOC version 6.0 and 4.2 distance unit is set to centimeter, the localization coordinates were rounded to the nearest millimeter which could affect positioning by 0.5 mm.
The Welch Allyn AED 20 product may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropiate therapy.
Holes in thermoformed tray compromising the sterility of the product.
Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media.
The text description of how to perform insulin sensitivity testing and associated worksheet included in the booklet that is shipped with the Paradigm 515 and Paradigm 715 insulin pumps contained a basic flaw in that the blood glucose after the correction should be compared to the target glucose and it says compare to the beginning blood glucose in the procedure.
Incorrect software version of instrument controller is not compatible with new configuration. This incorrect configuration may cause the instrument system to fail at start-up or during a run.
The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.
The Transport Chain is used to move a Reaction Tube within the Immulite 2000. It goes on to state the error condition that occurs due to a false trip of the home sensor.
Contaminated with Aspergillus and Penicillum molds.
Complaints received regarding the device's failure to zero out.
The actual power of the lenses may be different from what is indicated on the package labeling.
There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set.