Delta/Delta XL Monitors with Omega S Package
This recall has been terminated (originally issued December 29, 2009).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- November 9, 2009
- Posted
- December 29, 2009
- Terminated
- August 23, 2011
- Recall Number
- Z-0582-2010
- Quantity
- 4,188 units
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
Reason for Recall
monitor is rebooting/resetting
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.
Lot / Code Info
Catalog numbers MS18597 and MS18596
Root Cause
Software design
Action Taken
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.