Events

Recall of SOMATOM DEFINITION AS - MAIN UNIT

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
    23100
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-24
  • 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
    While performing a service call it was identified that a somatom definition as was missing the laser windows on the gantry front cover. it was identified that due to the gantry cover opening there is a risk for severe injury of the patient if he/she is to use the opening for stabilization or for support. further investigation revealed that the somatom definition as and the somatom definition flash were affected.

Device

SOMATOM DEFINITION AS - MAIN UNIT
  • Model / Serial
    Model Catalog: 8098027 (Lot serial: > 40 S/N CONTACT MFR)
  • Product Description
    SOMATOM DEFINITION AS-MAIN UNIT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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