Events

Recall of SYSMEX BLOOD COAGULATION ANALYZER CS-5100

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
    126891
  • Event Risk Class
    III
  • Event Initiated Date
    2017-08-10
  • 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
    Cs-5100 has a potential for a short circuit by a wiring between pcb and heater transistor or by malfunction of the transistor. in the worst case the overcurrent damages the pcb which may lead to a melting of the transistors until the instrument is powered off.

Device

SYSMEX BLOOD COAGULATION ANALYZER CS-5100
  • Model / Serial
    Model Catalog: CS-5100 (Lot serial: >10 contact mfg.)
  • Product Description
    SYSMEX Blood Coagulation CS-5100 analyzer
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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