Recall Z-0358-04 ยท FTD Lamp, Surgical
Draeger Medical, Inc.
Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp
| Date | Jan 22, 2004 (initiated Jan 9, 2004) |
| Status | Terminated |
| Reason | adjustment screw may break due to material fatigue |
| Root cause | Other |
| Action | The recalling firm issued a recall letter dated 1/9/03 to their direct accounts. The recall letter informed the accounts of the problem, the potential danger, and that they will be contacted to schedule replacement. |
| Quantity | 51 units |
| Distribution | Nationwide and Canada. The products were shipped to medical facilities in CA, CO, FL, GA, IL, IN, KS, MO, NC, NV, OH, TX, and VA. The product was also shipped to a medical facility in Canada. |
| 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 |