OEC 9900 systems 의 안전성 경고

Safety alert

2014-07-21

2014-07-21

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140721a.html

Medical device safety alert: ge healthcare oec 9900 systems medical device manufacturer, ge healthcare, has issued a field safety notice (fsn) concerning oec 9900 systems manufactured between 9 oct 2013 and 9 jun 2014, and oec 9900 systems that had an extension arm replaced between 9 oct 2013 and 9 jun 2014. the manufacturer issued an urgent medical device correction notice in earlier 2014 regarding a monitor arm screw issue. the screws that attach the workstation monitor spring arm to the extension arm may fail, causing the spring arm and monitor to tilt or fall forward. based on further investigation, the manufacturer is taking additional actions to correct the screws that attached the workstation monitor spring arm. the manufacturer advises users of the followings: use caution when positioning or extending the workstation articulating arm. refrain from positioning staff or patients directly underneath or in front of a workstation monitor. the manufacturer’s local field engineer will contact users to coordinate the replacement of the screws, and ensure that the system meets specifications. 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 21 july 2014.