FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
FDA device recall Z-1463-2014 · posted 2014-04-16 · Terminated
Recall details
- Recalling firm
- Solta Medical, Inc.
- Reason for recall
- Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.
- Action taken
- Solta Medical sent an Correction Important Product letter dated March 20, 2014 to affected customer. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the enclosed response form.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- ONG
- Quantity affected
- 1077 units
- Distribution
- Worldwide distribution
- Date initiated
- 2014-03-20
- Date posted
- 2014-04-16
- Date terminated
- 2015-04-27
- Location
- Hayward, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US (K101490) | Thermage, Inc. | 2010-09-08 |