FDA-Device2019-11-06Class II

SAROS Oxygen System Model 3000

Caire, Inc.
Hazard

There is an electronics control issue that causes the unit to not power on with battery power only.

Sold states
US and Chile
Affected count
10 units
Manufactured in
2200 Airport Industrial Dr Ste 500, Ball Ground, GA, United States
Products
SAROS Oxygen System Model 3000

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0248-2020

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