FRAXEL DUAL 1550/1927 Laser System recall
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Why was FRAXEL DUAL 1550/1927 Laser System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model MC-SYS-SR1500-D, Revisions A and B.
- Product
- FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
- Recalling firm
- Solta Medical, Inc.
- Quantity
- 1077 units
- Distribution
- Worldwide distribution
- Recall date
- April 23, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)