Recall Z-0582-2010 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draeger Medical, Inc.
Delta/Delta XL Monitors with Omega S Package
| Date | Dec 29, 2009 (initiated Nov 9, 2009) |
| Status | Terminated |
| Reason | monitor is rebooting/resetting |
| 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 | 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, Cos |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070566 | INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL Draeger Medical Systems, Inc., Jun 4, 2007 |