Events

Safety Alert for XiO Release 4.51 and higher

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

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
    2015-09-08
  • Event Date Posted
    2015-09-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150908a.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: impac medical systems xio release 4.51 and higher the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning xio release 4.51 and higher, manufactured by impac medical systems, inc. when fixed wedges are defined in source file maintenance, the user defines a maximum field size allowed for each wedge. this maximum field size is being ignored by the software when both fixed wedges and mlcs are present in a beam. the result is incorrect calculation and delivery of dose outside the physical extent of the wedge. the dose distribution calculated by xio will not match the dose delivered to the patient in regions beyond the physical dimension of the wedge. according to the field safety notice, varian, siemens and elekta linacs with motorized wedges will prevent delivery. however, elekta linacs with third party fixed wedges will not prevent delivery. xio will calculate wedged dose in the region outside of the physical wedge and the linac will deliver open dose. the patient will receive dose that is different from the planned dose and that dose difference can exceed 5%. there is a remote probability of serious injury resulting from this issue. the problem will be resolved in a patch to xio release 5.10. for details, please refer to the fda website:https://www.Gov.Uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-31-august-to-4-september-2015 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 september 2015.

Device

XiO Release 4.51 and higher
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: IMPAC Medical Systems XiO Release 4.51 and higher
  • Manufacturer
    IMPAC Medical Systems

Manufacturer

IMPAC Medical Systems
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    DH