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
    18564
  • Event Risk Class
    III
  • Event Initiated Date
    2013-12-10
  • 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
    Siemens has become aware that it is possible for patients or operators to have their fingers trapped and pinched between the table top and the bottom frame of the 550 txt treatment table which is part of the affected systems listed in section 64(a). secondly and unrelated siemens received a report on an incident in which a cable inside of the 550 txt treatment table had been damaged due to contacting a moving part. the resulting short-circuit caused overheating of an electronic circuit board inside the table base.

Device

ONCOR IMPRESSION IMRT PLUS
  • Model / Serial
    Model Catalog: 5857912 (Lot serial: 3779); Model Catalog: 7360717 (Lot serial: 5037); Model Catalog: 7360717 (Lot serial: 5041); Model Catalog: 7360717 (Lot serial: 5324); Model Catalog: 8139789 (Lot serial: 5414)
  • 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