Z-1010-2011

Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and...

Name: Z-1010-2011 Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and...
Creator: Solta Medical, Inc.
Published: 2010-12-15
License: https://open.fda.gov/license/

Solta Medical, Inc. / initiated 2010-12-15 / Terminated / root cause: software

FDA source

Solta Medical, Inc. began a recall of Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US... on 2010-12-15. The reason FDA records is "The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1010-2011
Status: Terminated
Initiated: 2010-12-15
Posted: 2011-02-01
Terminated: 2011-11-14
Recalling firm: Solta Medical, Inc.
Product: Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
Product code: ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Reason for recall: The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Solta Medical, issued three "DEVICE CORRECTION" letters, one dated December 15, 2010, the second one date December 17, 2010 and the third one dated December 20, 2010, to all affected customers. The letters described the product, problem and action to be taken by the customers. The customers were instructed to follow the instructions carefully, sign and date the bottom of the instruction form upon completion of the update and promptly return the signed form and USB stick in the enclosed, return-addressed envelope (Product Support, Solta Medical, 25881 Industrial Blvd., Hayward, CA 94545) Note: Solta Medical sales personnel will assist with the software update process so, if your local representative has already updated your system, you do not need to do anything further. If you have any questions, please call Solta Product Support at (510) 259-7291.
Quantity in commerce: 352 units
Distribution: Worldwide Distribution: USA and countries including: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Egypt, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Kuwait, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Poland, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, and Vietnam
Product codes and lots: Serial Numbers: F1196J, J0007, J0010-J0058, J0060-J0203, J0205, J0207-J0209, J0211-J0337, J0339-J0359, J0361-J0414, J0417-J0419, J0426

Product code ONG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)