Drager Surgical Lights Sola 500 and Sola 700.
FDA device recall Z-2212-2009 · posted 2009-09-16 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- welded seam may fail
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FTD
- Quantity affected
- 20 units
- Distribution
- Nationwide Distribution -- IL, KY, and PA.
- Date initiated
- 2009-08-26
- Date posted
- 2009-09-16
- Date terminated
- 2010-03-08
- 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 |