GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Reported: June 25, 2025 Initiated: May 8, 2025 #Z-1980-2025
Product Description
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
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.
Details
- Recalling Firm
- Ohio Medical Corporation
- Units Affected
- 36 units
- Distribution
- US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.
- Location
- Gurnee, IL
Frequently Asked Questions
What product was recalled? ▼
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S. Recalled by Ohio Medical Corporation. Units affected: 36 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 25, 2025. Severity: Moderate. Recall number: Z-1980-2025.
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