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
    72301
  • Event Risk Class
    III
  • Event Initiated Date
    2016-08-12
  • 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 determined that when certain steps occur there is a potential for the first and/or last name of one patient to be printed with patient id and result data from a different patient even though those fields have been turned off for the system.

Device

RAPIDPOINT 500 SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 10492730 (Lot serial: 10697306); Model Catalog: 106444 (Lot serial: 10291507); Model Catalog: 10492730 (Lot serial: 10696855); Model Catalog: 10492730 (Lot serial: 10492730); Model Catalog: 05320281 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 129887 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: 1265 (Lot serial: 10491395); Model Catalog: 1265 (Lot serial: 10321852); Model Catalog: 1265 (Lot serial: 10470366); Model Catalog: 1240 (Lot serial: 10491392); Model Catalog: 1240 (Lot serial: 10321840); Model Catalog: 106444 (Lot serial: 10339634); Model Catalog: 106444 (Lot serial: 10331381); Model Catalog: 106444 (Lot serial: 10328803); Model Catalog: 106444 (Lot serial: 10324081); Model Catalog: 106444 (Lot serial: 10322654); Model Catalog: 106444 (Lot serial: 10321239); Model Catalog: 106444 (Lot serial: 10318899); Model Catalog: 106444 (Lot serial: 10314585); Model Catalog: 10492730 (Lot serial: 10696857)
  • Product Description
    RAPIDPoint 500 Blood Gas Analyzer;RAPIDPoint 400 Blood Gas Analyzer;RAPIDPoint 405 Blood Gas Analyzer;RAPIDPoint 1265 Blood Gas Analyzer;RAPIDPoint 1260 Blood Gas Analyzer
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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