FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Reported: April 23, 2014 Initiated: March 20, 2014 #Z-1463-2014
Product Description
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
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.
Details
- Recalling Firm
- Solta Medical, Inc.
- Units Affected
- 1077 units
- Distribution
- Worldwide distribution
- Location
- Hayward, CA
Frequently Asked Questions
What product was recalled? ▼
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.. Recalled by Solta Medical, Inc.. Units affected: 1077 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2014. Severity: Moderate. Recall number: Z-1463-2014.
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