25-foot DC power cables shipped with Medrad Veris MR Vital Signs Monitors 의 안전성 경고

Safety alert

2013-04-26

2013-04-26

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130426a.html

Medical device safety alert: bayer healthcare 25-foot dc power cables shipped with medrad veris mr vital signs monitors medical device manufacturer, bayer healthcare, has issued a field safety notice concerning 25-foot dc power cables shipped with medrad veris mr vital signs monitors between february 2009 and february 2013 (catalogue number 3010556). according to the manufacturer, the affected power cables are being recalled due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket. when the dc power supply is connected to both ac power (wall outlet) and the dc power cable, excessive heating of the dc power cable may occur. the manufacturer advises users to have visual inspection of the dc power cable against recall criteria provided by the manufacturer. the affected dc power cables confirmed by visual inspection will be replaced with new dc power cables. in the interim, users can still use the dc power cables by following instructions for safe use of dc power cable provided by manufacturer. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 april 2013.