Draeger Infinity Acute Care System (IACS) Monitoring… recallZ-0939-2013 · Draeger Medical, Inc. · initiated Dec 13, 2012
Class II Terminated All recalls posted in March 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Draeger Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling design
What the company is doing
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.
Recall details
- Recall number
- Z-0939-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 13, 2012
- Posted by the FDA
- Mar 11, 2013
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 260
- Product code
- MHX
- FDA submissions
- K093788, K113798
- Distribution
- Distributed in the states of CA, IL, and MA.
Product description
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
Code information (models, lots, serial numbers)
Catalog Number MS20783 (Infinity MCable-Dual Hemo)
Other devices under the same FDA submission
5 devices cleared under K093788, K113798 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SHP UNT INFINITY M540 MS20401Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2 recalls5 deaths62 reports
- IACS w/C700 MS25520Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2 recalls1 death27 reports
- IACS w/C500 MS25510Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2 recalls2 deaths25 reports
- Infinity M540 MS26372Draeger Medical Systems, Inc. · System,Network And Communication,Physiological Monitors2 recalls9 reports
- Infinity Mpod Quad Hemo MS20725Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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