Events

Recall of DIMENSION VISTA SYSTEMS ALIQUOT PLATES

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
    81456
  • Event Risk Class
    III
  • Event Initiated Date
    2014-05-01
  • 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 investigated several "aliquot plate load failed" complaints. the green lid stock is visible separating form the white base of the aliquot plates causing the plate to not properly load onto the dimension vista? system. if a defective aliquot plate is placed in one of the three bays of the instrument aliquot plate holders for loading an error is generated: "aliquot plate load failed". the user needs to physically remove the plate from the aliquot plate holder and take the necessary steps to clear the error. unaffected aliquot plates load without an error.

Device

DIMENSION VISTA SYSTEMS ALIQUOT PLATES
  • Model / Serial
    Model Catalog: 10445210 (Lot serial: ALL)
  • Product Description
    ALIQUOT PLATES
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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