Recall of DIMENSION CHEMISTRY SYSTEM - REAGENT MANAGEMENT SYSTEM

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
    28932
  • Event Risk Class
    III
  • Event Initiated Date
    2012-07-11
  • 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
    Partial insertion of the power cord on the power input module can cause the plug to overheat and potentially create a fire hazard. dimension rms's without a power cord retention clip may be affected. as a precautionary measure siemens is recommending that customers inspect the dimension rms to determine if their system has a power cord retention clip.

Device

  • Model / Serial
    Model Catalog: 753000.902 (Lot serial: ); Model Catalog: 753000.902 (Lot serial: SERIAL NUMBERS:); Model Catalog: 753000.902 (Lot serial: 99060001 - 99062554)
  • Product Description
    DIMENSION CLINICAL CHEMISTRY SYSTEM-REAGENT MANAGEMENT SYSTEM
  • Manufacturer

Manufacturer

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