Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp
FDA device recall Z-0358-04 · posted 2004-01-22 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- adjustment screw may break due to material fatigue
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FTD
- Quantity affected
- 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.
- Date initiated
- 2004-01-09
- Date posted
- 2004-01-22
- Date terminated
- 2004-08-19
- Location
- Telford, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLA 700,SOLA 500, SOLA 300 (K010724) | Drager Medizintechnik GmbH | 2001-06-07 |