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