Recall Z-2212-2009 ยท FTD Lamp, Surgical
Draeger Medical, Inc.
Drager Surgical Lights Sola 500 and Sola 700.
| Date | Sep 16, 2009 (initiated Aug 26, 2009) |
| Status | Terminated |
| Reason | welded seam may fail |
| Root cause | Nonconforming Material/Component |
| Action | Draeger Medical, Inc. issued a "Medical Device Recall" letter dated August 2009 via certified mail with return receipt. Consignees were informed on the affected product and that a service representative will be in contact shortly to schedule a replacement. For further information, contact Draeger Medical at 1-800-543-5047, press 1 at the prompt and then 2349. |
| Quantity | 20 units |
| Distribution | Nationwide Distribution -- IL, KY, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010724 | SOLA 700,SOLA 500, SOLA 300 Drager Medizintechnik GmbH, Jun 7, 2001 |