Alerta De Seguridad para VERO /MHI-TM2000 linear accelerator system with software version 3.0.0 and after

Safety alert

2014-07-22

2014-07-22

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140722a.html

Medical device safety alert: mitsubishi vero /mhi-tm2000 linear accelerator system with software version 3.0.0 and after the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning vero /mhi-tm2000 linear accelerator system with software version 3.0.0 and after, manufactured by mitsubishi heavy industries ltd. accordingbased on internal investigation, the manufacturer found incorrectness with the condition set for rescheduling untreated fractions after the calendar setting is made. the record and verify system (r&v system) of the vero /mhi-tm2000 linear accelerator system has a calendar function used for treatment scheduling. because of a software bug, an unintended fraction is added to treatment schedule when holiday/workday setting is changed. according to the manufacturer, in case an added fraction is not detected by the user, unnecessary dose for the fraction will be given to the patient. it can cause death or serious injury of a patient depending on the treatment. the manufacturer advises users not to change calendar setting - from workday to holiday or vice versa - in r&v system until correction becomes available. however, if users must change the calendar setting, they must confirm whether any treatments, which are to be completed on the day that change is made, are added to each patient’s treatment schedule list as well as correct it manually when they find incorrect rescheduling. in addition, if users have to change treatment schedule in r&v system, the manufacturer reminds them to double-check the number of the fractions, date and time of the schedule each time until correction becomes available. if any unintended fraction is detected, it should be corrected manually. the manufacturer will contact all affected customers to schedule its installation. the tentatively planned availability date is end of august 2014. the manufacturer is creating a software tool to automatically check inconsistencies of patient treatment fractions in r&v system database. if an inconsistency problem is found, the manufacturer will further investigate it in collaboration with the customer to determine whether a potential mistreatment exists. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/home/groups/fsn/documents/fieldsafetynotice/con435839.Pdf if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 july 2014.