🏥 Medical Devices Class I - Dangerous
Product sterility compromised due to breach of sterile barrier
All Recalls
95,089 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
🏥 Medical Devices Class I - Dangerous
Product sterility compromised due to breach of sterile barrier
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
Organ Recovery Systems
🏥 Medical Devices Class I - Dangerous
Organ preservation fluid recalled due to potential for bacterial contamination.
🏥 Medical Devices Class I - Dangerous
Software error
🏥 Medical Devices Class I - Dangerous
Product sterility compromised due to breach of sterile barrier
Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the valve was set and the readings determined via an x-ray image.
packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.
🏥 Medical Devices Class I - Dangerous
Product sterility compromised due to breach of sterile barrier
🏥 Medical Devices Class I - Dangerous
Product sterility compromised due to breach of sterile barrier
🏥 Medical Devices Class I - Dangerous
There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements stated in the IFU. If Quality Control (QC) results are within acceptable limits, reported results are acceptable and were not affected by this issue.
🏥 Medical Devices Class I - Dangerous
Product sterility compromised due to breach of sterile barrier
🏥 Medical Devices Class I - Dangerous
Product sterility compromised due to breach of sterile barrier
Syngo.plaza, picture archiving and communications system.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Software update for improvements and to resolve several issues
MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Mevion Medical Systems
🏥 Medical Devices Class I - Dangerous
An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
🏥 Medical Devices Class I - Dangerous
Product sterility compromised due to breach of sterile barrier
🏥 Medical Devices Class I - Dangerous
Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit. The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/mL.
🏥 Medical Devices Class I - Dangerous
Product sterility compromised due to breach of sterile barrier
Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
PerkinElmer Life and Analytical Sciences, Wallac, OY
🏥 Medical Devices Class I - Dangerous
The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.
🏥 Medical Devices Class I - Dangerous
Product sterility compromised due to breach of sterile barrier