Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
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.
Class I - Dangerous
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.
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
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.
Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
Class I - Dangerous
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
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.
Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
Class I - Dangerous
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
Class I - Dangerous
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
Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
Class I - Dangerous
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.