Events

Recall of EASYLINK INFORMATICS SYSTEM V3

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
    26036
  • Event Risk Class
    II
  • Event Initiated Date
    2011-12-07
  • 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
    When using the easylink quality control package qc results may be unexpectedly associated with a pending control. when this situation occurs pending qc controls may be created or reused. these pending qc controls are not used to evaluate whether the qc result has violated a qc rule therefore qc status may not be flagged appropriately. in addition patient results that were intended to be held through qc-related auto-verification rules may be released to the laboratory information system without appropriate intervention. systems that are using the laboratory information system or another application to manage qc results may see similar behavior transferred to the other systems. this behavior can be experienced under two different circumstances each with a different potential resolution.

Device

EASYLINK INFORMATICS SYSTEM V3
  • Model / Serial
    Model Catalog: 1000034805 (Lot serial: )
  • Product Description
    EASYLINK INFORMATICS SYSTEM V5.0
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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