Medical device recalls Moderate risk

Caire, Inc. recalls SAROS Oxygen System Model 3000

Recall date
September 16, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0248-2020
FDA classification
Class II
Brand / firm
Caire, Inc.
Sold / distributed
US and Chile

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SAROS Oxygen System Model 3000

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