Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Stryker Navigation System II-Cart and Articulated Arm Camera

19 May 2015

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:

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

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