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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description Draeger Infinity Acute Care System Monitoring Solution
Recall Number Z-0714-2014
Classification Class II
Code Info with software versions VG2.0.3 and higher.
Product Distributed Qty 439
Reason For Recall After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.

Event Detail

Event Id 67056
Product Type Devices
Status Ongoing
Recalling Firm Draeger Medical Systems, Inc.
City Telford
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.