Recall Z-1980-2025
Ohio Medical Corporation · initiated May 8, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Codes / lots: Serial Numbers: ZL316367, ZL316446, ZL316462, ZL316475, ZL316481, ZL316484, ZL316490, ZL316493, ZL316503, ZL317057, ZL317087, ZL317088, ZL317090, ZL322386, ZL322387, ZL322390, ZL322392, ZL322409, ZL322412, ZL322439, ZL322441, ZL322442, ZL322443, ZL322445, ZL322447, ZL322451, ZL322455, ZL322456, ZL322462, ZL322463, ZL322466, ZL322467, ZL322470, ZL322472, ZL322473, ZL322837.
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.
FDA-determined cause: Device Design
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."
Details
- Recall number
- Z-1980-2025
- Initiated
- May 8, 2025
- Posted by FDA
- June 13, 2025
- Product code
- CAW – Generator, Oxygen, Portable
- Quantity
- 36 units
- Distribution
- US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.
- Recalling firm
- Ohio Medical Corporation, Gurnee, IL