Recall Z-1980-2025 ยท CAW Generator, Oxygen, Portable
Ohio Medical Corporation
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
| Date | Jun 13, 2025 (initiated May 8, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 c |
| Quantity | 36 units |
| Distribution | US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162433 | GCE Zen-O Portable Oxygen Concentrator Oxus, Inc., May 24, 2017 |