Medical Devices Recalls

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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.

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

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

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

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

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

Hazard: Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results.

Hazard: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.

Hazard: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.

Hazard: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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.

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

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

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

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

Hazard: Unexpected failure of electrical components within the CPI generator.

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

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

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

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

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