FDA-Device2025-06-25Class II
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Ohio Medical Corporation
Hazard
Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.
Sold states
US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.
Affected count
36 units
Manufactured in
1111 Lakeside Dr, N/A, Gurnee, IL, United States
Products
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1980-2025Don't want to check this manually?
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