Navigation System II-Cart and Articulated Arm Camera 의 안전성 경고

Safety alert

2015-05-19

2015-05-19

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150519.html

Medical device safety alert: stryker navigation system ii-cart and articulated arm camera medical device manufacturer, stryker instruments and stryker leibinger gmbh & co. kg, has issued a field safety notice concerning navigation system ii-cart and articulated arm camera, with the following details: navigation system ii-cart: product code 7700-100-000 distributed from 23 dec 2011 to 3 aug 2012 articulated arm camera: product code 7700-103-001 distributed from 23 dec 2011 to 3 aug 2012 articulated arm camera (refurbished): product code 7700-103-001u distributed from 23 dec 2011 to 3 aug 2012 according to the manufacturer, there is a potential that the weld seam between the main stud and the two flaps on the articulated arm was not welded in the correct location, which may result in failure of the arm joint. a failure in the weld joint could result in interruption or discontinued use of the navigation system. the manufacturer will perform inspection to all affected systems. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 may 2015.