🏥 Medical Devices Class I - Dangerous
A manufacturing error resulted in out of specification R3 Acetabular Shells
All Recalls
95,025 total recalls in our database
RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices 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.
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices 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.
RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
🏥 Medical Devices Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
🏥 Medical Devices Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.
🏥 Medical Devices Class I - Dangerous
Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
🏥 Medical Devices Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Biocare Medical
🏥 Medical Devices Class I - Dangerous
Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis.
🏥 Medical Devices Class I - Dangerous
Packaging of infant child reduced energy electrodes was not properly sealed.
🏥 Medical Devices Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
🏥 Medical Devices Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
🏥 Medical Devices Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
🏥 Medical Devices Class I - Dangerous
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
Philips Healthcare Informatics
🏥 Medical Devices Class I - Dangerous
Images may potentially become corrupt while using the system.
RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
Packaging of infant child reduced energy electrodes was not properly sealed.
RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices 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.