Complete FDA and NHTSA recall records dated in December 2023.
These records include useful source details for the selected month.
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
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…
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…
Their is a potential that intraocular implant devices may not meet specifications.
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
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…
Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.
Due to incorrect product/device within packaging.
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…
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.
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
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
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
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…
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…
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.
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…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
