Events

Recall of Sysmex CS-5100 Analyser. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty Ltd.

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
    RC-2017-RN-01098-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01098-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    There is the potential for a short circuit between the pcb (printed circuit board) and heater transistor or a malfunction of the transistor with the sysmex cs-5100. this may lead to smoke from the instrument, and in a worst case scenario, the overcurrent damaging the pcb, which may lead to a melting of the transistors until the instrument is powered off. this failure mode will occur if all of the conditions below are met:- pcb protection component blocks overcurrent by the short circuit- pcb protection component has a breakdown after a certain period with the instrument turned on- the overcurrent is throughout the pcb, which may lead to burn out unless the instrument is powered off.
  • Action
    Follow the instructions provided by Sysmex and confirm receipt of the information issued in August 2017. Complete and return the Response Form attached to the customer letter by Friday 22nd of September 2017. Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files and forward this information to all parties that may use a Sysmex CS-5100 system. A Siemens field service representative will visit and disconnect the connector on the PCB.

Device

Sysmex CS-5100 Analyser. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Sysmex CS-5100 Analyser. An in vitro diagnostic medical device (IVD)Siemens Material Number (SMN): 10709128Serial Numbers before 24425ARTG Number: 179939
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA