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U.S. Department of Health and Human Services

Class 2 Device Recall Infinity Delta/Gamma X XL Portable Monitor

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  Class 2 Device Recall Infinity Delta/Gamma X XL Portable Monitor see related information
Date Initiated by Firm June 04, 2010
Date Posted August 26, 2010
Recall Status1 Terminated 3 on July 30, 2012
Recall Number Z-2284-2010
Recall Event ID 55870
510(K)Number K070566  
Product Classification Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms) - Product Code MHX
Product Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
Code Information Catalog Number: MS18852
Recalling Firm/
Draeger Medical Systems, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Rececca Dolloff
Manufacturer Reason
for Recall
Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.
FDA Determined
Cause 2
Device Design
Action Draeger Medical issued "Urgent-Medical Device Recall Notification" letters to affected consignees. The Delta/Gamma X XL monitor keyboards will be updated with new material at each affected facility. If the keys on affected monitors become inoperative or activate without user interaction, the customer is instructed to remove the monitor from service and contact Draeger at 978-379-8573. A Technical Service Bulletin (TSB) will be distributed globally, instructing subsidiaries to inform international customers.
Quantity in Commerce 800 units
Distribution Worldwide Distribution - United States, including the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KS, LA, MA, ME, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, WO, and W, and the countries of United Arab Emirates, Angola, Argentina, Austria, Australia, Bosnia, Belgium, Bulgaria, Benin, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Serbia, Czech Republic, Germany, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Coratia, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Jordan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon,Lithuania, Latvia, Libya, Morocco, Macedonia, Martinique, Mexico, Netherlands, Norway, Nepal, Peru, Poland, Puerto Rico, Portugal, Qatar, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovak Republic, Turkmenistan, Turkey, Ukraine, Uruguay, Venezuela, Mayotte and South Africa. The government accounts are Bay Pines VAMC, Bay Pines, FL; Naval Medical Center, Portsmouth, VA; and Walter Reed Army Medical Center, Washington, DC.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = Draeger Medical Systems, Inc.