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Terminated

Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.

FDA Recall Z-0939-2013 · Posted 2013-03-11

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeMHX
Date Initiated2012-12-13
Date Terminated2013-05-20
Product Quantity260

Reason for Recall

The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.

Firm Action

Drager sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-543-5047 for questions relating to this notice.

Root Cause

Labeling design

Distribution Pattern

Distributed in the states of CA, IL, and MA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113798INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SETDraeger Medical Systems, Inc. · 2012-03-22K093788INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTIONDraeger Medical Systems, Inc. · 2010-03-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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