Device product

React Health PHOENIX 5L Oxygen Concentrator

Z-1815-2026

February 04, 2026

Class II

Product summary

Firm: 3B Medical, Inc.
Event: Event 98563
Status: Ongoing
Classification: Class II
Quantity: 2 units
Official record key: device-enforcement:Z-1815-2026

Official wording

Reason: Devices which did not meet internal quality specifications were inadvertently distributed.

Code information: UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009

Distribution pattern: US Nationwide distribution in the state of NY.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Devices which did not meet internal quality specifications were inadvertently distributed.