FDA-Device2026-04-22Class II
React Health PHOENIX 5L Oxygen Concentrator
3B Medical, Inc.
Hazard
Devices which did not meet internal quality specifications were inadvertently distributed.
Sold states
US Nationwide distribution in the state of NY.
Affected count
2 units
Manufactured in
5475 Rings Rd Ste 550, N/A, Dublin, OH, United States
Products
React Health PHOENIX 5L Oxygen Concentrator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1815-2026Original summary
React Health PHOENIX 5L Oxygen Concentrator Devices which did not meet internal quality specifications were inadvertently distributed. UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009 Distribution: US Nationwide distribution in the state of NY. Affected quantity: 2 units
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