Events

Recall of STRATUS CS 200

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
    79872
  • Event Risk Class
    III
  • Event Initiated Date
    2016-06-23
  • 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 has confirmed a software defect in the stratus cs acute care diagnostics system and stratus cs 200 acute care diagnostics system regarding testpak calibration and quality control (qc)status when a testpak is due to expire within 48 hours. depending on the calibration status either an above assay range (aar) or an inaccurate value could potentially be reported when running a testpak that is due to expire within 48 hours.

Device

STRATUS CS 200
  • Model / Serial
    Model Catalog: 10714016 (Lot serial: all lots); Model Catalog: 758000.901 (Lot serial: all lots)
  • Product Description
    STRATUS CS 200;STRATUS CS ACUTE CARE SYSTEM - FLOUROMETRIC ANALYZER
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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