Z-1463-2014 Class II Terminated
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.