Events

Safety Alert for Cranial Navigation System – Standard Cranial Reference Array

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

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
    2012-08-14
  • Event Date Posted
    2012-08-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120814.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
    Medical device safety alert: brainlab cranial navigation system – standard cranial reference array the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning cranial navigation system – standard cranial reference array manufactured by brainlab ag. manufacturing tolerances of the arrays influence the actual position of its marker spheres. the differences between the individual arrays are supposed to be very small, not significantly affecting navigation accuracy when the unsterile array is exchanged with the sterile array during surgery. however, according to the manufacturer, there are specific pairs of arrays that might add an inaccuracy of more than 1 mm to the registration result during the exchange due to the combination of their tolerance limits. this effect could potentially cause an inaccurate display of instruments by the navigation system in the region of interest, compared to the actual patient anatomy. if these inaccuracies are not detected by user verification of navigation accuracy as described in the user manual, this could lead to serious injury or ineffective treatment of the patient. customers are advised to remove the affected products from clinical use. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 august 2012.

Device

Cranial Navigation System – Standard Cranial Reference Array
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BrainLab Cranial Navigation System – Standard Cranial Reference Array
  • Manufacturer
    BrainLab AG

Manufacturer

BrainLab AG