Medical Devices Recalls

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

Pump not detected as connected to controller due to software issue.

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

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

Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.

There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.

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

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.

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

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

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.

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

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.

Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.

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

Due to incorrect product/device within packaging.

Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.

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.