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Recall Observatory FDA recall evidence

Device product

DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR

Z-1558-2023

March 09, 2023

Class II

Product summary

Firm
DeVilbiss Healthcare LLC
Event
Event 91804
Status
Ongoing
Classification
Class II
Quantity
143,397 units
Official record key
device-enforcement:Z-1558-2023

Official wording

Reason: The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.

Code information: Model 1025DS - UDI-DI: 00885304000846; Serial Numbers A175230001DS to A232160185DS; Model 1025UK - UDI-DI: 00885304022480; Serial Numbers A179210001US to A232060432US; Model 1025KS - UDI-DI: 00853040224734; Serial Numbers A176060001KS to A232220085KS; Model 1025KS-AR - UDI-DI: 00853040224734; Serial Numbers A216240003KS to A229210010KR

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.