Z-0714-2014 Class II Terminated
FDA device recall Z-0714-2014 was initiated by Draeger Medical Systems, Inc. on December 10, 2013 and is designated Class II. 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 va… The recall status is terminated (terminated May 20, 2015). Affected quantity: 439.
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2014
- Initiation Date
- December 10, 2013
- Termination Date
- May 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 439
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.
Distribution Pattern
US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
Code Information
with software versions VG2.0.3 and higher.