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

FDA device recall Z-1010-2011 · posted 2011-02-01 · Terminated

Recall details

Recalling firm

Solta Medical, Inc.

Reason for recall

The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

ONG

Quantity affected

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

Date initiated

2010-12-15

Date posted

2011-02-01

Date terminated

2011-11-14

Location

Hayward, CA

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