Home / Recalls / DeVilbiss Healthcare LLC / Z-1558-2023

Z-1558-2023 Class II Ongoing

Recalled by DeVilbiss Healthcare LLC — Somerset, PA

Recall Details

Product Type
Devices
Report Date
May 10, 2023
Initiation Date
March 9, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
143,397 units

Product Description

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

Reason for Recall

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

Distribution Pattern

Worldwide - US Nationwide distribution.

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

Other recalls by DeVilbiss Healthcare LLC

  • Z-0724-2023 Class II — DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q (November 18, 2022)
  • Z-0229-2023 Class II — 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration o (September 19, 2022)
  • Z-2246-2016 Class II — DeVilbiss Model 7305P-D Powered Suction Unit (May 23, 2016)
  • Z-1949-2014 Class III — DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Ap (May 13, 2014)
  • Z-2319-2013 Class II — DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 (March 7, 2013)