Ohio Medical Corporation recalls GCE HEALTHCARE Zen-O lite

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.

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."

• FDA enforcement recordOfficial FDA database entry for Z-1980-2025
• FDA 510(k) clearance · K162433The device's official FDA premarket clearance record
• FDA device classification · CAWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Ohio Medical CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.