Important Safety Alerts

Important Safety Alerts

Field Safety Notice: Smith & Nephew 560P High Definition Camera Control Unit

30 Mar 2012

Medical device manufacturer, Smith & Nephew Inc., issued a field safety notice concerning certain 560P High Definition Camera Control Unit [Product code: 72201919; Serial No.: BBS1203 & BBS1450]. User of the device may experience intermittent loss of video due to a defective board component, which was incorporated during the manufacturing process.

According to the manufacturer, there is a risk of inadvertent damage to non-target tissue while visualization is not functioning correctly if loss of video or display is experienced during the surgical procedure.

According to the local supplier, the affected devices were distributed to Hong Kong.

For more details, please refer to the attachment. If you are in possession of the product, please contact your supplier for necessary actions.

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