STAR Excimer Laser System 의 안전성 경고

Safety alert

2013-09-25

2013-09-25

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130925.html

Medical device safety alert: abbott medical optics star excimer laser system medical device manufacturer, abbott medical optics (amo) ltd, has issued a field safety notice concerning amo star excimer laser system. the affected models are s2, s3, s4 and s4 ir. amo is providing an advisory notice to all customers who use the affected products to make aware of an issue that has the potential to result in loss of illumination due to an unexpected failure of a component under high use conditions of the oblique and ring illumination lamps. this issue can be traced to a specific component found in a limited amount of star systems. if the system is found to have the component, amo will replace a printed circuit board in the laser at the next service visit. in the unlikely event that the star system loses both oblique and ring illumination, users are advised to contact the manufacturer for assistance. in addition, amo recommends users to use the lowest level of illumination required during the patient treatment in order to reduce high use conditions caused by the oblique and ring illumination lamps being on simultaneously. it is recommended that only two oblique lamps be used (not activating the optional third oblique lamp) in order to further reduce the remote possibility of complete illumination loss. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 september 2013.