Draeger Medical Systems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0714-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Draeger Infinity Acute Care System Monitoring Solution

Product Classification:

Class II

Date Initiated: December 10, 2013

Date Posted: January 22, 2014

Recall Number: Z-0714-2014

Event ID: 67056

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.

Status: Terminated

Product Quantity: 439

Code Information:

with software versions VG2.0.3 and higher.

Distribution Pattern:

US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.

Voluntary or Mandated:

Voluntary: Firm initiated