Field Safety Notices about Rotem Sigma Complete and Rotem Sigma Complete + Hep Cartridge

According to Health Sciences Authority (HSA), this field safety notices involved a device in Singapore that was produced by Unimed Healthcare Pte Ltd.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    600:41/01-118/16/01_61
  • Date
    2016-03-22
  • Event Country
  • Event Source
    HSA
  • Event Source URL
  • Notes / Alerts
    Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 Singapore.
  • Extra notes in the data
    TEM International GmbH

Device

  • Model / Serial
  • Product Description
    Rotem Sigma Complete and Rotem Sigma Complete + Hep Cartridge, TEM International GmbH
  • Manufacturer

Manufacturer