Fraxel re:store Dual Laser System 의 안전성 경고

Safety alert

2011-02-11

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20110211.html

Safety concern on fraxel re:store dual laser systemthe 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 on medical devices, noticed that the us food and drug administration (fda) has announced that the product’s manufacturer, solta medical inc., is recalling all the affected devices for corrective actions. 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 the information from local supplier, solta medical inc., at least three machines were imported to 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 actions. so far, the 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 actions. ends/friday, february 11, 2011.