Ohio Medical Corporation recalls GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
- Recall date
- May 8, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1980-2025
- FDA classification
- Class II
- Brand / firm
- Ohio Medical Corporation
- Sold / distributed
- US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
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