Events

Recall of Expression MR200 MRI Patient Monitoring System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invivo Corporation.

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
    69192
  • Event Risk Class
    Class 2
  • Event Number
    Z-0001-2015
  • Event Initiated Date
    2014-09-08
  • Event Date Posted
    2014-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129828
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
  • Reason
    During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. the metallic debris could affect system performance due to the potential for a failure to power up or loss of power. this could result in the loss of monitoring and a delay in diagnosis of the patient.
  • Action
    The firm, Philips Healthcare, sent an "URGENT- Medical Device Recall" letter dated June 17, 2014, to its customers informing them of the product, problem and actions taken. The firm informed the customers that there are no additional actions required on their part. The Philips/Invivo Account Manager will contact them in order to arrange for replacement of the device. If you need any further information or support concerning this issue, contact your local Philips/Invivo representative: 877-468-4861 option 1, then option 2.

Device

Expression MR200 MRI Patient Monitoring System
  • Model / Serial
    Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.
  • Product Description
    Philips Expression MR200 MRI Patient Monitoring System Model 866120
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • Manufacturer Address
    Invivo Corporation, 12151 Research Pkwy, Suite 200, Orlando FL 32826-3222
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA