Z-0582-2010

Delta/Delta XL Monitors with Omega S Package

Name: Z-0582-2010 Delta/Delta XL Monitors with Omega S Package
Creator: Draeger Medical, Inc.
Published: 2009-11-09
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2009-11-09 / Terminated / root cause: software

FDA source

Draeger Medical, Inc. began a recall of Delta/Delta XL Monitors with Omega S Package on 2009-11-09. The reason FDA records is "monitor is rebooting/resetting". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0582-2010
Status: Terminated
Initiated: 2009-11-09
Posted: 2009-12-29
Terminated: 2011-08-23
Recalling firm: Draeger, Inc.
Product: Delta/Delta XL Monitors with Omega S Package
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: monitor is rebooting/resetting
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Catalog numbers MS18597 and MS18596

Product code MHX

K070566Class IIInfinity Delta/delta Xl/ Kappa/ Gamma X Xl/ Vista Xl/ Sc7000/sc8000/ Sc9000xlDraeger Medical Systems, Inc. / cleared 2007-06-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)