Solta Medical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1463-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.

Product Classification:

Class II

Date Initiated: March 20, 2014

Date Posted: April 23, 2014

Recall Number: Z-1463-2014

Event ID: 67835

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.

Status: Terminated

Product Quantity: 1077 units

Code Information:

Model MC-SYS-SR1500-D, Revisions A and B.

Distribution Pattern:

Worldwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated