Events

Safety Alert for neuro / inspire - surgical planning software

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

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
    2014-11-11
  • Event Date Posted
    2014-11-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141111.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: renishaw neuro / inspire - surgical planning software the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning neuro / inspire - surgical planning software (product code: a-5630-3000-a6 and a-5630-3001-a4; software version: 4.0.1665.3; lot numbers: all), manufactured by renishaw. the manufacturer’s internal processes have discovered a bug in neuro inspire v4.0.1665.3 that could potentially result in the software getting into an indeterminate state under certain circumstances. if neuro inspire gets into this state, it may affect surgical planning activities and/or the quality of data produced as an output. this bug may result in a delay to the surgical procedure which in turn may extend the application of general anaesthetic, and risk of infection may also be raised on this basis. the bug may lead to a targeting error that could potentially result in permanent long term injury or life threatening injury to the patient. users should not use the affected products for any clinical procedure until further notice. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con471136 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 november 2014.

Device

neuro / inspire - surgical planning software
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Renishaw neuro / inspire - surgical planning software
  • Manufacturer
    Renishaw

Manufacturer

Renishaw