Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa… recallZ-0281-2012 · Draeger Medical, Inc. · initiated Oct 31, 2011

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number

Z-0281-2012

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Oct 31, 2011

Posted by the FDA

Nov 23, 2011

Recalling firm

Draeger Medical, Inc.

Quantity

14,894

Product code

MHX

FDA submissions

K070566

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 description

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).

Other devices under the same FDA submission

5 devices cleared under K070566 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Delta Monitor MS18597

  Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  2 deaths11 reports
• DeltaXL Monitor MS18596

  Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  5 reports
• Infinity Vista XL Monitor MS18986

  Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  1 death4 reports
• Infinity Kappa Monitor MS18853

  Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  4 reports
• Infinity Gamma XXL MS18852

  Draeger Medical Systems, Inc. · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  1 report