Events

Recall of SURVEYOR PATIENT MONITORS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MORTARA INSTRUMENT INC..

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
    91680
  • Event Risk Class
    III
  • Event Initiated Date
    2014-10-09
  • 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
    A hazardous situation may be created during installation when mounting these monitors (surveyor s12 and surveyor s19) using the 75mm vesa mounting hold 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 then 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.

Device

SURVEYOR PATIENT MONITORS
  • Model / Serial
    Model Catalog: SUR12-XXX-XXXXX (Lot serial: all lots); Model Catalog: SUR19-XXX-XXXXX (Lot serial: all lots)
  • Product Description
    Surveryor Patient Monitors
  • Manufacturer
    MORTARA INSTRUMENT INC.

Manufacturer

MORTARA INSTRUMENT INC.