Events

Recall of DIMENSION VISTA SYSTEM - DIMENSION VISTA 500 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
    55981
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-08
  • 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 has confirmed that under a rare set of conditions when utilizing the routine inventory screen to enter a user defined method (empty) flex the system may assign the user defined method flex to a different flex that is currently in inventory on the system and then use the incorrect flex cartridge to process the user defined method. investigation of the issue has determined that this error will only occur if the assign empty reagent cartridge window has been left open and the flex inventory on the system changes.

Device

DIMENSION VISTA SYSTEM - DIMENSION VISTA 500 ANALYZER
  • Model / Serial
    Model Catalog: 1000034648 (Lot serial: all lots); Model Catalog: 1000033793 (Lot serial: all lots)
  • Product Description
    DIMENSION VISTA SYSTEM - DIMENSION VISTA 500 ANALYZER
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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