Z-1463-2014 Class II Terminated
FDA device recall Z-1463-2014 was initiated by Solta Medical, Inc. on March 20, 2014 and is designated Class II. 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. The recall status is terminated (terminated April 27, 2015). Affected quantity: 1077 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 23, 2014
- Initiation Date
- March 20, 2014
- Termination Date
- April 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1077 units
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.
Distribution Pattern
Worldwide distribution
Code Information
Model MC-SYS-SR1500-D, Revisions A and B.