Events

Recall of RAPIDPOINT 500 SYSTEM - MAIN UNIT

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
    30913
  • Event Risk Class
    III
  • Event Initiated Date
    2013-09-24
  • 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
    Users can inadvertently enter a wrong patient id on the demographics screen which ultimately could lead to a misidentification of the sample. a patient sample mismatch could be caused by: 1. inadvertently accepting the pre-selected patient id on the demographics screen 2. overwriting sample demographics by incorrect operation of the patient list button 3. scanning the wrong barcode id 4. manually typing in the wrong id in each of these cases failure to check the correct demographics screen before moving on to the results screen will assign the wrong demographics to the sample being tested.

Device

RAPIDPOINT 500 SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: RAPIDPOINT 500 (Lot serial: ); Model Catalog: 10492730 (Lot serial: ); Model Catalog: 1260 (Lot serial: ); Model Catalog: RAPIDPOINT 405 (Lot serial: ); Model Catalog: 05320281 (Lot serial: ); Model Catalog: 1245 (Lot serial: ); Model Catalog: 1265 (Lot serial: ); Model Catalog: 1240 (Lot serial: ); Model Catalog: 129887 (Lot serial: ); Model Catalog: 106444 (Lot serial: ALL S/N FOR ALL DEVICES)
  • Product Description
    RAPIDPOINT 500 SYSTEM-MAIN UNIT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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