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U.S. Department of Health and Human Services

Class 2 Device Recall Delta/Delta XL Monitors with Omega S Package

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  Class 2 Device Recall Delta/Delta XL Monitors with Omega S Package see related information
Date Initiated by Firm November 09, 2009
Date Posted December 29, 2009
Recall Status1 Terminated 3 on August 23, 2011
Recall Number Z-0582-2010
Recall Event ID 53875
510(K)Number K070566  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Delta/Delta XL Monitors with Omega S Package
Code Information Catalog numbers MS18597 and MS18596
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Technical Support
800-543-5047
Manufacturer Reason
for Recall		 monitor is rebooting/resetting
FDA Determined
Cause 2		 Software design
Action Draeger Medical Systems, Inc. issued and Urgent Medical Device Recall letter dated November 2009 to their affected customers informing them of the problem and a work around until software can be validated. A Technical Service Bulletin has been generated and distributed globally that instructs the affected International Drager subsidiaries to inform customers in their countries. For further information, contact Draeger Medical Systems, Inc. at 1-800-543-5047, extension 1-2349.
Quantity in Commerce 4,188 units
Distribution The product was shipped to medical facilities in CA, CO, CT, ID, IN, KY, MS, NY, OK, and WI. The product was also shipped to United Arab Emirates, Argentina, Austria, Australia, Bosnia Herz, Belgium, Benin, Brunei Darussalam, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Croatia, Hungary, Ireland, India, Iran, Italy, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Lithuania, Latvia, Libya, Morocco, Mexico, Malaysia, Netherlands, Norway, Nepal, Oman, Poland, Portugal, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovak Republic, Thailand, Turkey, Taiwan, Ukraine, Venezuela, Vietnam, and South Africa.
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.
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