Recall Z-1980-2025— Ohio Medical Corporation
Class II · Ongoing
Class II FDA medical device recall by Ohio Medical Corporation, initiated 2025-05-08. It names one FDA 510(k) clearance: K162433. 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..
- Recalling firm
- Ohio Medical Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-08
- Firm location
- Gurnee, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.