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
    44298
  • Event Risk Class
    III
  • Event Initiated Date
    2015-01-08
  • 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 is sending an urgent field safety notice to customers to remind them that the neonatal bilirubin (nbili) parameter on the rapidpoint 405 rapidpoint 500 rapidlab 1245 and rapidpoint 1265 analyzers may have increased variability when the nbili concentration is >12 mg/dl (205 micro mol/l) and the thb concentration exceeds the upper reportable range of >25 g/dl (15.5mmol/l). when this occurs the analyzer may report a nbili result that is higher or lower than expected.

Device

RAPIDPOINT 500 SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: RAPIDPOINT 500 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: RAPIDPOINT 405 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 1265 (Lot serial: ALL SERIAL NUMBERS)
  • 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