Events

Recall of S5 IMAGING SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by THE LIFEMED GROUP INC..

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
    31968
  • Event Risk Class
    II
  • Event Initiated Date
    2013-05-23
  • 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
    Volcano corporation received a total of three complaints in which the user reported that the display on the system changed.

Device

S5 IMAGING SYSTEM
  • Model / Serial
    Model Catalog: (Lot serial: > 10 numbers contact mfg); Model Catalog: 435-0602.02 (Lot serial: > 10 numbers contact mfg); Model Catalog: 435-0602.01 (Lot serial: > 10 numbers contact mfg); Model Catalog: 435-0607.04 (Lot serial: > 10 numbers contact mfg); Model Catalog: 435-0607.01 (Lot serial: > 10 numbers contact mfg); Model Catalog: 435-0602.02 (Lot serial: N/A); Model Catalog: 435-0602.01 (Lot serial: N/A); Model Catalog: 435-0607.04 (Lot serial: N/A); Model Catalog: 435-0607.01 (Lot serial: N/A)
  • Product Description
    S5 IMAGING SYSTEM
  • Manufacturer
    THE LIFEMED GROUP INC.

Manufacturer

THE LIFEMED GROUP INC.