Z-0281-2012

Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the...

Name: Z-0281-2012 Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the...
Creator: Draeger Medical, Inc.
Published: 2011-10-31
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2011-10-31 / Terminated / root cause: software

FDA source

Draeger Medical, Inc. began a recall of Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection... on 2011-10-31. The reason FDA records is "Firm received 2 complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Masimo SET pod is used for SpO2 measurements". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0281-2012
Status: Terminated
Initiated: 2011-10-31
Posted: 2011-11-23
Terminated: 2013-07-01
Recalling firm: Draeger, Inc.
Product: Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms).
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Firm received 2 complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Masimo SET pod is used for SpO2 measurements.
Root cause tag: software
FDA root cause: Software design
Action: Firm initiated their recall of this device on October 25, 2011 by sending an "Urgent Medical Device Recall" letter to consignees. A Technical Service Bulletin will be generated and distributed globally that instructs the affected International Draeger subsidiaries to inform customers in their countries. The software anomaly has been corrected in software version 7.3. Draeger Service Representatives will schedule time with customers to upgrade the software in affected monitors. The software upgrade will be provided free of charge.
Quantity in commerce: 14,894
Distribution: Worldwide distribution- USA including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SD, TN, TX, UT, VA, WI and WV and International distribution including the countries of Algeria, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Botswana, Brasilien, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Deutschland, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Finland, France, Frankreich, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indien, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Jordanien, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Madagascar, Malaysia, Malta, Mauritius, Mayotte, Mexico, Moldavia, Moldova, Morocco, Netherlands, Norway, Norway, Peru, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Rumania, Russian Fed., Saudi Arabia, Serbia, Seychelles, Singapore, Slovenia, Slowenien, South Africa, South Korea, Spain, Sri Lanka, S¿dafrika, Sweden, Switzerland, Syria, Taiwan, Thailand, Tschechische Republic, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and White Russia.
Product codes and lots: Catalog Number(s): MS18597 and MS18852, Software versions: VF6.2, VF6.3, VF6.4, VF7.1 and VF7.2

Product code MHX

K070566Class IIInfinity Delta/delta Xl/ Kappa/ Gamma X Xl/ Vista Xl/ Sc7000/sc8000/ Sc9000xlDraeger Medical Systems, Inc. / cleared 2007-06-04

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)