GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
FDA device recall Z-1980-2025 · posted 2025-06-13 · Open, Classified
Recall details
- Recalling firm
- Ohio Medical Corporation
- 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.
- Action taken
- Ohio Medical issued a Field Safety Notice to its consignees on 05/08/2025 followed by telephone calls on 05/13/2025. The notice explained the problem with the device, potential risk, and requested the devices be returned for correction. The notice further stated: "The Field Safety Notice is communicated to all impacted customers and is communicated to competent authorities in the affected markets. Receivers should pass this FSN on to all persons with a need to be advised from within your organization or to any organization where the potentially affected products have been supplied. Please consider end users and others within the supply chain in the circulation of this notice."
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- CAW
- Quantity affected
- 36 units
- Distribution
- US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.
- Date initiated
- 2025-05-08
- Date posted
- 2025-06-13
- Location
- Gurnee, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GCE Zen-O Portable Oxygen Concentrator (K162433) | Oxus, Inc. | 2017-05-24 |