95,114 total recalls in our database
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
Integra LifeSciences
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Staar Surgical Company
Their is a potential that intraocular implant devices may not meet specifications.
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Integra LifeSciences
Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
Integra LifeSciences
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Staar Surgical Company
Their is a potential that intraocular implant devices may not meet specifications.
Heartware
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Maquet Medical Systems USA
Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.
Stryker Medical Division of Stryker
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Staar Surgical Company
Their is a potential that intraocular implant devices may not meet specifications.
Stryker Medical Division of Stryker
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Thor Photomedicine
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
Stryker Medical Division of Stryker
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Thor Photomedicine
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
Staar Surgical Company
Their is a potential that intraocular implant devices may not meet specifications.