The Department of Health (DH) today (February 11) warned healthcare professionals and beauty industry operators that the Fraxel re:store Dual Laser System runs the risk of causing inadvertent laser firing which may lead to patient/operator injury.
DH, through its routine surveillance of medical devices, noticed that the US Food and Drug Administration(FDA) had announced that the product's manufacturer, Solta Medical Inc., is recalling all the affected devices for corrective action.
Fraxel re:store Dual Laser System is a laser surgical instrument for use in general and plastic surgery and in dermatology.
A DH spokesman said, "There is a risk of causing skin burn under high energy setting and small spot size."
The model numbers and serial numbers of the devices involved are:
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
Serial Numbers:
F1196J; J0007; J0010-J0058; J0060-J0203; J0205; J0207-J0209; J0211-J0337; J0339-J0359; J0361-J0414; J0417-J0419; J0426
According to information from the local supplier, Solta Medical Inc., at least three machines were imported into Hong Kong. Two were sold to local healthcare professionals and one was used as a demonstration machine. The supplier has contacted the local users for immediate corrective action.
So far, DH has not received any report of adverse events arising from use of the affected products.
DH has informed all public and private hospitals and medical professional associations about the matter and advised them to remain vigilant.
While DH will continue to monitor the development, the spokesman urged healthcare professionals and operators of beauty parlours who are using the affected device to stop using it, and contact the local supplier for immediate corrective action.
Reprinted from HKSAR Government web page:
http://www.info.gov.hk/gia/general/201102/11/P201102110276.htm