Class 2 Device Recall GCE HEALTHCARE ZenO lite

• Date Initiated by Firm: May 08, 2025
• Date Posted: June 13, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1980-2025
• Recall Event ID: 96851
• 510(K)Number: K162433
• Product Classification: Generator, oxygen, portable - Product Code CAW
• Product: GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
• Code Information: 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.
• Recalling Firm/ Manufacturer: Ohio Medical Corporation; 1111 Lakeside Dr; Gurnee IL 60031-2489
• For Additional Information Contact: Jessica Barrile; 847-855-6318
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CAW