Events

Recall of Surveyor S12 and Surveyor S19 Patient MonitorsMultiple part numbers and serial numbers affected

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Mortara Instrument Australia 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-2014-RN-01108-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01108-1
  • 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
    Mortara instrument, inc. has recently become aware of a potential safety hazard involving surveyor s12 and surveyor s19 patient monitors. a hazardous situation may be created when mounting these monitors using the 75mm vesa mounting hole pattern provided in the battery cover of these monitors. if the mounting screws provided by mortara are not used and if the mounting screws used are longer than the provided screws, it is possible for the longer screws to be driven completely through the battery cover and then possibly penetrate the protective casing of the lithium-ion battery which may result in a fire. there have been no reported incidents of fire, injury or death due to this potential safety hazard. a correction has been developed to eliminate the potential risk. thecorrection alters the design of the battery cover, creating a barrier that prevents mounting screws from penetrating into the battery compartment.
  • Action
    A Mortara Instrument Australia service representative will be contacting affected customers to schedule an update that includes replacement of the battery cover and replacement of the battery pack if mounting screw damage is evident. This update is at no cost to the customer. This action has been closed-out on 1/03/2016.

Device

Surveyor S12 and Surveyor S19 Patient MonitorsMultiple part numbers and serial numbers affected
  • Model / Serial
    Surveyor S12 and Surveyor S19 Patient MonitorsMultiple part numbers and serial numbers affectedManufactured March, 2012 to September, 2014ARTG Number: 215421
  • Manufacturer
    Mortara Instrument Australia Pty Ltd

Manufacturer

Mortara Instrument Australia Pty Ltd