Reported Apr 23, 2014 · Terminated
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Solta Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Solta Medical, Inc. · 25881 Industrial Blvd · Hayward, CA · 94545-2991
Is this the product you have?
FRAXEL DUAL 1550/1927 Laser System(FRAXEL SR 1500 DUAL Laser System)for dermatological procedures
- Lot codes and dates
- Model MC-SYS-SR1500-D, Revisions A and B.
- Amount recalled
- 1077 units
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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