Urgent recall issued for TrueAire-5 oxygen concentrator
By HME News Staff
Updated 10:50 AM CST, Thu February 6, 2025
WASHINGTON – The U.S. Food and Drug Administration has issued an urgent recall for the JMCC5A Ni/TruAire-5 Oxygen Concentrator due to the device spontaneously catching fire. The FDA says all units from a specified serial number range must be immediately discontinued from use and removed from service and promptly returned to Compass Health Brands. The affected devices are Model O2C5L with serial number range JA2311000001-JA2312000740. On Nov. 26, 2024, Jiangsu Jumao X-Care Medical Equipment Co. sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
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Notify customers that have received units within the affected serial number range of this recall and the requirement to replace their oxygen concentrator.
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Complete and return the medical device recall return response acknowledgment and receipt form to Compass Health Brands within 15 calendar days of receipt.
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Response form must be returned even if you have no stock or have no record of purchasing this device.
The cause of the fires and melting remains under investigation. The use of affected product may cause serious adverse health consequences, including exposure to excess heat and fire that could lead to burns and possibly death. There have been no reported injuries. There have been no reports of death.
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