Recall of DIMENSION XPAND SYSTEM - XPAND PLUS WITH HM ANALYZER - 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
    21551
  • Event Risk Class
    III
  • Event Initiated Date
    2018-01-16
  • Event Country
  • 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
    Manufacturer identified an issue with dimension? software version 10.2.1. the software version does not permit the user to enter or edit calibration coefficients for applicable assays without support from a siemans customer service representative.

Device

  • Model / Serial
    Model Catalog: 765000.931 (Lot serial: 2001081906); Model Catalog: 778041.911 (Lot serial: DE270253); Model Catalog: 765000.921 (Lot serial: 2004081160)
  • Product Description
    DIMENSION XPAND SYSTEM - XPAND PLUS with hm analyzer - class 2;DIMENSION EXL 200 ANALYZER;DIMENSION XPAND SYSTEM - XPAND PLUS WITH HM ANALYZER;DIMENSION XPAND PLUS BASIC ANALYZER - class 2;DIMENSION XPAND SYSTEM - XPAND PLUS Basic Analyzer
  • Manufacturer

Manufacturer

  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
  • Source
    HC