Z-1980-2025Class II

GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

Name: Z-1980-2025 GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Creator: Ohio Medical Corporation
Published: 2025-05-08
License: https://open.fda.gov/license/

Ohio Medical LLC / initiated 2025-05-08 / Open, Classified / root cause: design

FDA source

Ohio Medical Corporation began a recall of GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S on 2025-05-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1980-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-08
Posted: 2025-06-13
Recalling firm: Ohio Medical LLC
Product: GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Product code: CAW Generator, Oxygen, Portable
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.
Root cause tag: design
FDA 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 consider end users and others within the supply chain in the circulation of this notice."
Quantity in commerce: 36 units
Distribution: US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1980-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1980-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-13

Product code CAW

K162433Class IIGCE Zen-O Portable Oxygen ConcentratorOxus, Inc. / cleared 2017-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)