Class II

Medical Device Recall: GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

Ohio Medical Corporation · May 8, 2025

Reason for Recall

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.

Distribution

US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.

States Affected

NATIONWIDE

Quantity Affected

36 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1980-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Ohio Medical Corporation Medical Device Recall: GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S | SafeCheck