Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessible. 2. The handle can separate from the MRx housing due to breakage of mounts on the rear case.
Class I - Dangerous
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
Shimadzu Medical Systems
Class I - Dangerous
The C-arm may interfere with the table top under certain circumstances.
Class I - Dangerous
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
Innokas Medical Oy
Class I - Dangerous
Monitor may shut down unintentionally without restarting.
Class I - Dangerous
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
Class I - Dangerous
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
Focus Diagnostics
Class I - Dangerous
Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
Inaccurate distance measurements with magnified projection X-ray images.
GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Philips Medical Systems (Cleveland)
Class I - Dangerous
The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.
Class I - Dangerous
Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has demagnetized.
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Philips Medical Systems
Class I - Dangerous
1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication
MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed
Class I - Dangerous
There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results.
Inaccurate distance measurements with magnified projection X-ray images.
Class I - Dangerous
The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.