Recall Z-0714-2014— Draeger Medical Systems, Inc.

Name: FDA recall Z-0714-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-10

Class II · Terminated

Class II FDA medical device recall by Draeger Medical Systems, Inc., initiated 2013-12-10, terminated 2015-05-20. It names one FDA 510(k) clearance: K113798. Product: Draeger Infinity Acute Care System Monitoring Solution. Reason: 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..

Recalling firm: Draeger Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-10
Terminated: 2015-05-20
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K113798 — INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SETDraeger Medical Systems, Inc.·cleared 2012-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Draeger Infinity Acute Care System Monitoring Solution

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.