Recall Z-1558-2023— DeVilbiss Healthcare LLC

Name: FDA recall Z-1558-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-09

Class II · Ongoing

Class II FDA medical device recall by DeVilbiss Healthcare LLC, initiated 2023-03-09. It names one FDA 510(k) clearance: K071397. Product: DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR. 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..

Recalling firm: DeVilbiss Healthcare LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-03-09
Firm location: Somerset, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K071397 — DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIESSunrise Medical·cleared 2007-10-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.