Other Medical Devices

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.

Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 mL) is expected to continue to drop over time as iodine vapors continue to dissipate from the bottles.

There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia may lead to iatrogenic hyponatremia, resulted in a delay in patient diagnosis and optimal patient management.

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

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

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.

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.