Medical equipment, implants, and diagnostic devices
Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Carefusion 2200
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Carefusion 2200
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Carefusion 2200
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Carefusion 2200
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Philips North America
Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not followed, and may also cause the monitor to stop operating or prevent it from being switched on.
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
The needle surface deteriorated due to unexpected electrolysis during procedure.
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Philips North America
The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more technical or INOP alarms.
Carefusion 2200
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Becton Dickinson & Company
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Carefusion 2200
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.
QC inspection observed that a portion of the lot may have been contaminated with blood.
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Carefusion 2200
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Siemens Medical Solutions USA
If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in Synthetic CT , the software does not recognize the adapted acquisition plane. This may result in images with wrong geometry. When this distortion remains unnoticed and the images are subsequently exported to a treatment planning system (TPS), an incorrect calculated radiation treatment plan cannot be excluded. The occurence of this issue is very unlikely and has never been reported so far.