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Draeger Infinity Acute Care System Monitoring Solution

FDA Recall #Z-0714-2014 — Class II — December 10, 2013

Recall #Z-0714-2014 Date: December 10, 2013 Classification: Class II Status: Terminated

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.

Recalling Firm

Draeger Medical Systems, Inc. — Telford, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

439

Distribution

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.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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