[pending] GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Pending LLM rewrite. Source: FDA_DEVICE Z-1980-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
- Manufacturer
- Ohio Medical Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: ZL316367
- ZL316446
- ZL316462
- ZL316475
- ZL316481
- ZL316484
- ZL316490
- ZL316493
- ZL316503
- ZL317057
- ZL317087
- ZL317088
- ZL317090
- ZL322386
- ZL322387
- ZL322390
- ZL322392
- ZL322409
- ZL322412
- ZL322439
Distribution
Distributed nationwide across the United States.
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