Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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).

FDA Recall Z-0281-2012 · Posted 2011-11-23

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeMHX
Date Initiated2011-10-31
Date Terminated2013-07-01
Product Quantity14,894

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070566INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XLDraeger Medical Systems, Inc. · 2007-06-04

Official Source

View FDA Recall →

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

↑