Z-0939-2013Class II

Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual...

Name: Z-0939-2013 Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual...
Creator: Draeger Medical, Inc.
Published: 2012-12-13
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2012-12-13 / Terminated / root cause: labeling and UDI

FDA source

Draeger Medical, Inc. began a recall of Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system on 2012-12-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0939-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-13
Posted: 2013-03-11
Terminated: 2013-05-20
Recalling firm: Draeger, Inc.
Product: Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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.
Quantity in commerce: 260
Distribution: Distributed in the states of CA, IL, and MA.
Product codes and lots: Catalog Number MS20783 (Infinity MCable-Dual Hemo)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0939-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0939-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-11

Product code MHX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)