Events

Recall of 3160 MRI PATIENT MONITORING SYSTEM - POWER BATTERY COMPONENTS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INVIVO A DIVISION OF PHILIPS MEDICAL SYSTEMS.

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
    74346
  • Event Risk Class
    II
  • Event Initiated Date
    2009-01-27
  • 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
    The lithium polymer battery may fail after being physically dropped from a height. failed battery may momentarily produce a flamme and then emit smoke. the failure may occur instantly or after short period.

Device

3160 MRI PATIENT MONITORING SYSTEM - POWER BATTERY COMPONENTS

Manufacturer

INVIVO A DIVISION OF PHILIPS MEDICAL SYSTEMS
  • Manufacturer Address
    ORLANDO
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC