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DeVilbiss Healthcare Recalls
6 recalls on record · October 9, 2013 to May 10, 2023 · Medical Devices
Recalls by year
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16
22
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 10, 2023Medical DevicesFDA
DeVilbiss Healthcare LLC recalls DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Hazard: The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
December 28, 2022Medical DevicesFDA
DeVilbiss Healthcare LLC recalls DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Hazard: The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.
November 23, 2022Medical DevicesFDA
DeVilbiss Healthcare LLC recalls 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 12
Hazard: An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
July 27, 2016Medical DevicesFDA
DeVilbiss Healthcare LLC recalls DeVilbiss Model 7305P-D Powered Suction Unit
Hazard: A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
July 9, 2014Medical DevicesFDA
DeVilbiss Healthcare LLC recalls DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of pos
Hazard: A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST".
October 9, 2013Medical DevicesFDA
DeVilbiss Healthcare LLC recalls DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML D
Hazard: End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable.