Events

Recall of STRATUS CS ACUTE CARE SYSTEM - PBNP TESTPAK

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
    149790
  • Event Risk Class
    III
  • Event Initiated Date
    2012-03-30
  • 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 conducted an internal investigation of calibration failures due to slope errors that are not resolved with routine maintenance. a low frequency occurrence of this issue has been confirmed for certain stratus cs testpak lots as they approach their expiration date.

Device

STRATUS CS ACUTE CARE SYSTEM - PBNP TESTPAK
  • Model / Serial
    Model Catalog: CPBNPM (Lot serial: 211227002); Model Catalog: CPBNPM (Lot serial: 211283002); Model Catalog: CPBNPM (Lot serial: 211297002); Model Catalog: CPBNPM (Lot serial: 211339002); Model Catalog: CPBNPM (Lot serial: 212003002); Model Catalog: CPBNPM (Lot serial: 211214002); Model Catalog: CPBNPM (Lot serial: 212023002)
  • Product Description
    STRATUS CS ACUTE CARE SYSTEM-PBNP TESTPAK
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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