PHILIPS MEDICAL SYSTEMS NEDERLAND B.V Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 recall — FDA Z-1155-2025
Possibility of the patient falling from the table related to the mattress used on the patient table.
Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
21,924 detailed records are currently available in this category.
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.
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…
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…
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…
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.
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…
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…
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…
Possibility of the patient falling from the table related to the mattress used on the patient table.
Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin…
Possibility of the patient falling from the table related to the mattress used on the patient table.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential that the induction seal is not completely sealed to the device tube packaging.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
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