FDA Device recall Z-1980-2025
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
- FDA Device
- Class II
- ongoing
- Published 2025-06-25
On 2025-06-25 the FDA classified a Class II recall of GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S by Ohio Medical, citing 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 purit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1980-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-08 |
| Published | 2025-06-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ohio Medical |
| Distribution | US |
Product
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
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.
Identifiers
| code_info | Serial Numbers: ZL316367, ZL316446, ZL316462, ZL316475, ZL316481, ZL316484, ZL316490, ZL316493, ZL316503, ZL317057, ZL…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1980-2025%22
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