Events

Recall of ADVIA CENTAUR XP SYSTEM - INSTRUMENT CLASS 2

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
    129863
  • Event Risk Class
    III
  • Event Initiated Date
    2014-02-21
  • 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 the advia centaur xp immunoassay system instrument cover is raised the cover is supported by a gas spring attached at the middle of the cover. over time the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. this may lead to the cover falling during maintenance procedures.

Device

ADVIA CENTAUR XP SYSTEM - INSTRUMENT CLASS 2
  • Model / Serial
    Model Catalog: 078-A010-07 (Lot serial: >10 NUMBERS (CONTACT MFR)); Model Catalog: 09066916 (Lot serial: >10 NUMBERS (CONTACT MFR))
  • Product Description
    ADVIA CENTAUR XP SYSTEM - CLASS 2
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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