Events

Recall of E.CAM SIGNATURE SERIES

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
    54587
  • Event Risk Class
    II
  • Event Initiated Date
    2016-03-01
  • 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 user error complaints regarding injuries resulting from collimator change siemens has determined that for e.Cam or symbia e systems although the existing user manual is correct additional supplemental instructions with the inclusion of visual aids may further clarify and emphasize the proper collimator change process. a customer advisory notice is being issued to advise customers that siemens is providing an addendum to the symbia e and e.Cam user manual with specific enhancements to the instructions for collimator change. incidents during collimator change may be avoided by operators properly following specified instructions.

Device

E.CAM SIGNATURE SERIES
  • Model / Serial
    Model Catalog: 07333235 (Lot serial: ALL); Model Catalog: 07333284 (Lot serial: ALL); Model Catalog: 10275879 (Lot serial: SN 1012)
  • Product Description
    E.CAM SIGNATURE SERIES;SYMBIA E DUAL HEAD SYSTEM
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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