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
    127055
  • Event Risk Class
    II
  • Event Initiated Date
    2016-03-31
  • 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 received customer complaints of discrepant siemens healthcare diagnostics has received customer complaints of discrepant patient results on dimension vista intelligent lab systems. siemens healthcarepatient results on dimension vista intelligent lab systems. siemens healthcare diagnostics has confirmed a software defect which in a very specific set of circumstances results in the dimension vista system omitting an aliquot probe rinse between sample aspirations when processing tubes in sample racks that are front loaded on the dimension vista system. omission of the aliquot probe rinse may result in carryover of residual sample estimated up to 10% when the sample is dispensed into the aliquot well. carryover of residual sample from the outside of the aliquot probe into the sample tube is estimated at less than 0.1%.

Device

DIMENSION VISTA SYSTEM - DIMENSION VISTA 1500 ANALYZER
  • Model / Serial
    Model Catalog: 1000033793 (Lot serial: ALL); Model Catalog: 1000034648 (Lot serial: ALL)
  • 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