GCE HEALTHCARE Zen-O lite portable oxygen concentrators with specific serial numbers have erroneous calibration that may cause inaccurate low oxygen purity alarms as the device ages.
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.
Ohio Medical Corporation is recalling GCE HEALTHCARE Zen-O lite portable oxygen concentrators with certain serial numbers due to potential calibration errors. This could cause the device to give incorrect low oxygen purity alarms as the units age, which might lead to unsafe oxygen levels for users.
The device may develop calibration errors over time, causing it to incorrectly signal low oxygen purity when the actual oxygen levels are safe. This could lead to users not knowing when their oxygen levels are dangerously low.
Patients using the recalled Zen-O lite oxygen concentrators with specific serial numbers are most at risk. The recall affects individuals who rely on this portable oxygen device for medical treatment.
Check for the model number RS-00608-X-S and the specific serial numbers listed in the recall notice. The affected units have serial numbers starting with ZL316367 through ZL322473.
Verify your device's serial number against the list of affected numbers provided in the recall notice.
The device may develop calibration errors over time, causing it to give incorrect low oxygen purity alarms as it ages.
Check if your device has the model number RS-00608-X-S and a serial number from the list provided in the recall notice.
Check your device's serial number against the list of affected numbers. If it matches, you should stop using it until you can get a replacement or repair.
We’ve drafted a message you can send GCE HEALTHCARE to request your refund or repair — edit it as you like.
Subject: Recall Z-1980-2025 — GCE HEALTHCARE GCE HEALTHCARE Hello, I own a GCE HEALTHCARE that is covered by recall Z-1980-2025 from GCE HEALTHCARE. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
