07

Jan

2010

Delta/Delta XL Monitors with Omega S Package Cl Il

0

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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