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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Event Detail

Event ID 67835
Product Type Devices
Status Ongoing
Recalling Firm Solta Medical, Inc.
City Hayward
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-20
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures. Model MC-SYS-SR1500-D, Revisions A and B. Class II Solta Medical became aware that 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. 1077 units Z-1463-2014