There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126
Geistlich Pharma North America
Class I - Dangerous
Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane
Class I - Dangerous
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Class I - Dangerous
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Class I - Dangerous
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.
Class I - Dangerous
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices.
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
Coloplast Manufacturing US
Class I - Dangerous
Potential increased occurrence of pump fracture over the lifetime of the device.
Class I - Dangerous
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices.
Class I - Dangerous
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Class I - Dangerous
Incorrect hip components were provided in kits.
Class I - Dangerous
Under certain conditions, there is a risk for fire.
Class I - Dangerous
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.
Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116
Geistlich Pharma North America
Class I - Dangerous
Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane
Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115
Geistlich Pharma North America
Class I - Dangerous
Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane
EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
Encore Medical
Class I - Dangerous
There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.