Medical Devices Recalls

Possibility of the patient falling from the table related to the mattress used on the patient table.

Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .

Possibility of the patient falling from the table related to the mattress used on the patient table.

Possibility of the patient falling from the table related to the mattress used on the patient table.

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

Possibility of the patient falling from the table related to the mattress used on the patient table.

Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.

There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.

Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.

Possibility of the patient falling from the table related to the mattress used on the patient table.

Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .

Possibility of the patient falling from the table related to the mattress used on the patient table.

Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.

Possibility of the patient falling from the table related to the mattress used on the patient table.

Possibility of the patient falling from the table related to the mattress used on the patient table.

Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

Possibility of the patient falling from the table related to the mattress used on the patient table.

Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

Possibility of the patient falling from the table related to the mattress used on the patient table.