Events

Recall of DIMENSION VISTA SYSTEM - DIMENSION VISTA 1500 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
    24475
  • Event Risk Class
    II
  • Event Initiated Date
    2015-05-20
  • 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
    Issue # 1: manufacturer received complaints for samples not processing without notification on the dimension vista 500 or dimension vista 1500 using software versions 3.6.1 in most cases user action of pause / cancel pause is effective in restoring lane operation and the samples will resume processing. however in a few cases it was necessary to shutdown the instrument software and restart to recover. in all cases the affected samples are resubmitted and run successfully. issue # 2: manufacturer received complaints for unexpected less than lower assay range (

Device

DIMENSION VISTA SYSTEM - DIMENSION VISTA 1500 ANALYZER
  • Model / Serial
    Model Catalog: 1000033793 (Lot serial: >10 contact mfg.); Model Catalog: 1000034648 (Lot serial: >10 contact mfg.); Model Catalog: (Lot serial: >10 contact mfg.)
  • Product Description
    DIMENSION VISTA SYSTEM - DIMENSION VISTA 1500 Analyzer
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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