95,114 total recalls in our database
RAYSEARCH LABORATORIES AB
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components.
RAYSEARCH LABORATORIES AB
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
There is potential for the plastic optical tip to become detached from the metal shaft.
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
There is potential for the plastic optical tip to become detached from the metal shaft.
RAYSEARCH LABORATORIES AB
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
There is potential for the plastic optical tip to become detached from the metal shaft.
There is potential for the plastic optical tip to become detached from the metal shaft.
Distributed to the field without having completed design history files or design transfer activities
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Distributed to the field without having completed design history files or design transfer activities
There is potential for the plastic optical tip to become detached from the metal shaft.
There is potential for the plastic optical tip to become detached from the metal shaft.
A manufacturing error resulted in out of specification R3 Acetabular Shells
There is potential for the plastic optical tip to become detached from the metal shaft.
Distributed to the field without having completed design history files or design transfer activities
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
INARI MEDICAL
The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device must be used or suboptimal thrombus removal if the problem is not detected.