Ohio Medical Corporation is recalling 36 units of GCE Healthcare Zen-O lite Portable Oxygen Concentrators (Model RS-00608-X-S) due to incorrect calibration values. As these devices age and oxygen purity naturally decreases, the alarm system intended to alert the user to low oxygen levels may fail to trigger at the correct threshold. No injuries or incidents have been reported to date regarding this issue.
The defect may cause the device to provide oxygen with low purity without alerting the user via the expected alarm. This could result in the patient receiving insufficient oxygen therapy, which poses a health risk particularly for those dependent on supplemental oxygen.
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Recall Number: Z-1980-2025
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Sources: FDA iRES · Raw API Response
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