Other Medical Devices

Incorrect CT to ED when using the Monaco Image Statistics Tool.

The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

The recalled devices labeling and instructions for use contain unapproved medical claims.

Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.

The toothbrush head can potentially disengage from the handle.

The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.

The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle.

If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place.

The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.

Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.

If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place.

If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place.

Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion). Mixing valves need to be replaced at regular intervals.

Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled cuff diameter and the actual cuff diameter. The actual product cuff diameter meets required specification.

Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.

The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.

Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.

Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.

Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.