Other Medical Devices

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.

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

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.

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

Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.

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.

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

There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.

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.

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

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.

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

Affected lots of product may experience technical distortions to a greater extent than expected.