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
    23408
  • Event Risk Class
    III
  • Event Initiated Date
    2015-07-29
  • 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 has issued an urgent field safety notice to inform customers of potential when both ports (serial and ethernet) are configured to transmit data the data stream from one port could potentially affect the data stream from the other port. this could cause the message received by the lis (data management system) to include either: duplicate data missing data data from a different patient. siemens has not observed this scenario and the expected frequency of occurrence is extremely unlikely. if this issue occurs only one analyte has the potential to be affected (i.E. if a panel of analytes is ordered only one could be affected).

Device

RAPIDPOINT 500 SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: RAPIDPOINT 500 (Lot serial: ALL)
  • Product Description
    RAPIDPOINT 500 SYSTEM
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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