95,050 total recalls in our database
Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified
Cardinal Health 200
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Terumo Medical
There is a potential for a loss of package integrity that may compromise the sterility of the product.
LABORIE MEDICAL TECHNOLOGIES
Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard
Siemens Medical Solutions USA
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Randox Laboratories, Limited
There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.
Siemens Medical Solutions USA
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
Cardinal Health 200
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Siemens Medical Solutions USA
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Siemens Medical Solutions USA
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Potential for tube leakage
Siemens Medical Solutions USA
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Medical Intelligence Medizintechnik Gmbh
Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan.
An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
Cardinal Health 200
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
Siemens Medical Solutions USA
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Siemens Medical Solutions USA
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Cardinal Health 200
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product