Events

Field Safety Notices about iGUIDE® 2.1, iGUIDE® 2.2

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Medical Intelligence Medizintechnik GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    If by mistake the initial pre-treatment imaging was performed before the hexapod was moved to the drive (*start) position, iguide offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data. this should avoid the need to redo imaging with hexapod in drive (*start) position. in this scenario the software may prompt you several times to move the hexapod to its drive (*start) position. if you follow this request the hexapod will move to drive (*start). in a consecutive step iguide shows hints to move the couch top with the precise table back to the initial imaging position. however, this position is reached only with a coarse movement. a final fine adjustment move, executed by the hexapod, is missing. the coarsely reached imaging position becomes the new registered position for the actual position error correction (pec) movement to the target position. a theoretical additional error of max. ± 2 mm in three dimensions, in respect to the true target position, can occur due to the missing fine movement. .

Device

iGUIDE® 2.1, iGUIDE® 2.2

Manufacturer

Medical Intelligence Medizintechnik GmbH
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    AMPMDRS