| 2023-03-09 |
Class II
|
Ongoing |
Z-1558-2023 |
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR |
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The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard. |
| 2022-11-18 |
Class II
|
Ongoing |
Z-0724-2023 |
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q |
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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 pat… |
| 2022-09-19 |
Class II
|
Ongoing |
Z-0229-2023 |
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 12… |
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An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway) |