Medical Devices Recalls

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

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

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

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

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

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.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Their is a potential that intraocular implant devices may not meet specifications.

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

Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

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.

Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

Their is a potential that intraocular implant devices may not meet specifications.

Their is a potential that intraocular implant devices may not meet specifications.