Company:Draeger Medical, Inc.
Date of Enforcement Report 1/6/2010
Class:ll
PRODUCT
Delta/Delta XL Monitors with Omega S Package. Catalog numbers MS18597 and MS18596. Recall # Z-0582-2010
REASON
Monitor is rebooting/resetting.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, PA, by letter dated November 2009.
Manufacturer: Draeger Medical Systems Inc., Danvers, MA. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4,188 units
DISTRIBUTION
CA, CO, CT, ID, IN, KY, MS, NY, OK, WI, 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.
