Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This leak can occur sporadically in affected systems.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Class I - Dangerous
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Class I - Dangerous
After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
Class I - Dangerous
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Class I - Dangerous
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Qiagen Sciences
Class I - Dangerous
Potential for obtaining a false positive result due to the possibility of endotoxin presence.
McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
Mckesson Medical Immaging
Class I - Dangerous
McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a patient.
Class I - Dangerous
Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to the data loss or in the worst case to an erroneous assignment of the patient data (patient mismatch). The issue will only occur at sites using POTCT1-A communication via USB.
Class I - Dangerous
The firm discovered that the incorrect lot number was engraved on the product.
Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
Deerfield Imaging
Class I - Dangerous
Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
Class I - Dangerous
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
Class I - Dangerous
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).
GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
Class I - Dangerous
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).