🏥 Medical Devices Class I - Dangerous
Potential for leakage due to defect in the thermoset check valve component.
All Recalls
95,064 total recalls in our database
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
Abbott Ireland Diagnostics Division
🏥 Medical Devices Class I - Dangerous
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
🏥 Medical Devices Class I - Dangerous
🏥 Medical Devices Class I - Dangerous
Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
In2bones USA
🏥 Medical Devices Class I - Dangerous
The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit.
🏥 Medical Devices Class I - Dangerous
Alinity i Estradiol Reagent Kit, List Number 07P5020
Abbott Ireland Diagnostics Division
🏥 Medical Devices Class I - Dangerous
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
🏥 Medical Devices Class I - Dangerous
Alinity i Free T4 Reagent Kit, List Number 07P7030
Abbott Ireland Diagnostics Division
🏥 Medical Devices Class I - Dangerous
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
🏥 Medical Devices Class I - Dangerous
If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.
🏥 Medical Devices Class I - Dangerous
Potential for leakage due to defect in the thermoset check valve component.
🏥 Medical Devices Class I - Dangerous
Potential for leakage due to defect in the thermoset check valve component.
🏥 Medical Devices Class I - Dangerous
Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays
GEM Coupler Forceps, GEM4183C, packaged individually.
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Potential presence of rust on Coupler Forceps (GEM4183C).
🏥 Medical Devices Class I - Dangerous
Potential compromise of product sterility due to breach of sterile barrier.
Alinity i TSH Reagent Kit, List Number 07P4830
Abbott Ireland Diagnostics Division
🏥 Medical Devices Class I - Dangerous
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
Abbott Ireland Diagnostics Division
🏥 Medical Devices Class I - Dangerous
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19
🏥 Medical Devices Class I - Dangerous
Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.