Events

Safety Alert for 560P High Definition Camera Control Unit

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Smith & Nephew.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-03-30
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120330.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: smith & nephew 560p high definition camera control unit 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.

Device

560P High Definition Camera Control Unit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Smith & Nephew 560P High Definition Camera Control Unit
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew