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Terminated

SAROS Oxygen System Model 3000

FDA Recall Z-0248-2020 · Posted None

Recalling FirmCaire, Inc.
Recall StatusTerminated
Product CodeCAW
Date Initiated2019-09-16
Date Terminated2020-12-16
Product Quantity10 units

Reason for Recall

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

Firm Action

The firm initiated the recall by email on 09/16/2019. The firm explained the issue and requested the return of the units.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US and Chile

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083163OMNI 2 OXYGEN SYSTEMSequal Technologies, Inc. · 2009-10-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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