🏥 Medical Devices • 15,809 recalls
Philips Electronics North America
System may lock up.
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Fresenius Medical Care Renal Therapies Group
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Customer complaints received for the presence of leaks
Damaged packaging, lack of sterility assurance
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
The Binding Site Group
If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.
Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
Fresenius Medical Care Renal Therapies Group
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Fresenius Medical Care Renal Therapies Group
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).
Complaints of sheath separation, kinking, and/or tip damage during use.
Complaints of sheath separation, kinking, and/or tip damage during use.
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Meridian Bioscience
Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
Complaints of sheath separation, kinking, and/or tip damage during use.