Drug recall
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
FDA recall event 67835 · Class II · Solta Medical, Inc.
Key facts
| Event ID | 67835 |
|---|---|
| Recall numbers | Z-1463-2014 |
| Recalling firm | Solta Medical, Inc. |
| Product type | Devices |
| Products | FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Mar 20, 2014 |
| Report date | Apr 23, 2014 |
| Termination date | Apr 27, 2015 |
| City | Hayward |
| State | CA |
| Country | United States |
| FEI number | 3003079710 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: