Class I - Dangerous
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Possible corrosion of the battery contact(s).
xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.
Luminex Molecular Diagnostics
Class I - Dangerous
Reports have been received of lower MS2 MFI values when using the panel.
Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX using a LAN driver may be recorded in the patients chart or electronic medical record at exactly 100 times the actual bolus rate, infusion rate and total volume values
Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX using a LAN driver may be recorded in the patients chart or electronic medical record at exactly 100 times the actual bolus rate, infusion rate and total volume values
Class I - Dangerous
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Class I - Dangerous
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Class I - Dangerous
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Class I - Dangerous
Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom.
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
Leica Microsystems
Class I - Dangerous
The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and can cause serious injuries.
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Could cause burn and shock injuries to users and a delay in test results. Device design has mitigated this risk, but it is a possibility.
Class I - Dangerous
Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.
The products are mislabeled.
The products are mislabeled.
Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.