Events

Recall of ADVIA 120 HEMATOLOGY SYSTEM - ANALYZER

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
    28981
  • Event Risk Class
    II
  • Event Initiated Date
    2013-07-02
  • 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 healthcare diagnostics is conducting a field corrective action for advia 120 hematology systems. the advia 120 optics cover or hood is located on the very top of the advia 120 analyzer. when the optics cover is raised it is supported by two gas struts which are attached to the cover on the left and right sides. over time it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. this could cause the cover to fall during maintenance procedures.

Device

ADVIA 120 HEMATOLOGY SYSTEM - ANALYZER
  • Model / Serial
    Model Catalog: 10360959 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 10360958 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    ADVIA 120 HEMATOLOGY SYSTEM - ANALYZER
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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