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Ohio Medical Corporation recalls GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Recalled June 25, 2025 · FDA recall Z-1980-2025 · Ohio Medical
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. · FDA Class II
Units
36 units
Sold at
US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.
Description
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.
Product
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Manufacturer(s)
Ohio Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →