🏥 Medical Devices • 6,554 recalls
Edwards Lifesciences
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Edwards Lifesciences
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Edwards Lifesciences
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Aizu Olympus Co.
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.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Roche Diagnostics Operations
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short, deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.