Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1558-2023 — DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR

U.S. FDA — Device Enforcement · United States · 2023-03-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1558-2023
Date of alert
2023-03-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DeVilbiss Healthcare LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00885304000846
Reported risk: The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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