Events

Recall of Medrad Veris MR Vital Signs Monitor, power cable

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Bayer Healthcare LLC.

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
    14751
  • Event Initiated Date
    2013-06-06
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Technisonic Systems 2013 Ltd, 2B Target Court, Wairau Valley, Glenfield, Auckland 6027
  • Reason
    Due to a latent design reliability issue there is potential for electrical shorting which can result in heating/melting of the cable jacket.
  • Action
    Product to be modified

Device

Medrad Veris MR Vital Signs Monitor, power cable
  • Model / Serial
    Model: Catalogue: 3010556, Affected: All serial numbers
  • Manufacturer
    Bayer Healthcare LLC

Manufacturer

Bayer Healthcare LLC
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    NZMMDSA