Events

Recall of ONCOR IMPRESSION IMRT PLUS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    18759
  • Event Risk Class
    II
  • Event Initiated Date
    2014-03-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    As a result of investigation into complaints related to the treatment table (txt) that is part of the linear accelerators the following safety issues were identified: 1. in very rare instances the actual table position may significantly deviate from the position at the table side control and the linac control console but no interlock occurs. 2. in sporadic cases the following issue for the table axis lateral longitudinal and isocentric rotation occurs: after a manual table movement with released brake an immediate automatic movement for the same table axis is not possible.

Device

ONCOR IMPRESSION IMRT PLUS
  • Model / Serial
    Model Catalog: 5857912 (Lot serial: 3799); Model Catalog: 8139789 (Lot serial: 5414); Model Catalog: 7360717 (Lot serial: 5324); Model Catalog: 7360717 (Lot serial: 5041); Model Catalog: 7360717 (Lot serial: 5037)
  • Product Description
    ONCOR IMPRESSION IMRT PLUS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC