Class I - Dangerous
The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
DeVilbiss Healthcare
Class I - Dangerous
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.
Class I - Dangerous
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Class I - Dangerous
A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
Class I - Dangerous
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".
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.