Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems 의 안전성 경고

Safety alert

2013-09-10

2013-09-10

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130910.html

Medical device safety alert: ge advantx, innova 2000, innova 2100iq, innova 3100, innova 3100iq, innova 4100, innova 4100iq cardiovascular x-ray imaging systems the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning all advantx, innova 2000, innova 2100iq, innova 3100, innova 3100iq, innova 4100, innova 4100iq cardiovascular x-ray imaging systems equipped with video monitor suspension manufactured by ge healthcare. systems equipped with lcd or large display monitor suspensions are not affected. it has been identified during several preventive maintenance activities that the 4 outer screws that hold the overhead video monitor suspension to the carriage were found missing since installation of the system. there is a potential that the system has not been installed per specified installation requirements. the manufacturer is not aware of any fall of the overhead monitor suspension. however, missing screws may increase the risk for fall of the monitor suspension. no injury has been reported due to this issue. the manufacturer will inspect all potentially affected systems to verify that the overhead video monitor suspensions are properly installed and will correct all affected systems. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con309649 if you are in possession of the product, please contact your supplier for necessary actions. posted on 10 september 2013.