AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed
🏥 Medical Devices Class I - Dangerous
The failure to detect the partial obstruction in a 2.5mm sensor.
All Recalls
95,018 total recalls in our database
Intera 1.5T Achieva Nova, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed
🏥 Medical Devices Class I - Dangerous
The failure to detect the partial obstruction in a 2.5mm sensor.
🏥 Medical Devices Class I - Dangerous
Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.
Intera 1.5T Achieva IT Nova, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Intera 1.0T Omni/Stellar, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
GYROSCAN ACS-NT, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
🏥 Medical Devices Class I - Dangerous
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
Achieva XR, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Ingenia 1.5T CX, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
🏥 Medical Devices Class I - Dangerous
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
Ingenia Elition S, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica¿ CI Analyzer and Atellica¿ CH Analyzer Siemens Material Number (SMN): 11537211
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results.
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Randox Laboratories
🏥 Medical Devices Class I - Dangerous
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
🏥 Medical Devices Class I - Dangerous
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Randox Laboratories
🏥 Medical Devices Class I - Dangerous
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
🏥 Medical Devices Class I - Dangerous
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility