Delta/Delta XL Monitors with Omega S Package
FDA device recall Z-0582-2010 · posted 2009-12-29 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- monitor is rebooting/resetting
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 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,
- Date initiated
- 2009-11-09
- Date posted
- 2009-12-29
- Date terminated
- 2011-08-23
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL (K070566) | Draeger Medical Systems, Inc. | 2007-06-04 |