🏥 Medical Devices Class I - Dangerous
Packaging of infant child reduced energy electrodes was not properly sealed.
All Recalls
95,114 total recalls in our database
🏥 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.
RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - 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.
STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.
RayStation 8B Service Pack 1, UDI # 07350002010204 - 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
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
Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
Siemens Healthcare Diagnostics
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Elekta Limited
🏥 Medical Devices Class I - Dangerous
In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.
🏥 Medical Devices Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
Siemens Healthcare Diagnostics
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.