Medical Devices Recalls

Hazard: Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.

Hazard: Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.

Hazard: The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results

Hazard: Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

Hazard: Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.

Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

Hazard: Device is missing the pin in the graft loader component.

Hazard: Device is missing the pin in the graft loader component.

Hazard: Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately

Hazard: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Hazard: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Hazard: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Hazard: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Hazard: The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Hazard: Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.

Hazard: Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).

Hazard: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Hazard: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Hazard: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Hazard: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Hazard: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Hazard: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Hazard: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.