Events

Recall of Philips 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
    69587
  • Event Risk Class
    Class 2
  • Event Number
    Z-0958-2015
  • Event Initiated Date
    2014-10-22
  • Event Date Posted
    2015-01-13
  • 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=130997
  • 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
    The mr 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of patient monitoring or user/service electrical shock.
  • Action
    Philips Medical Systems sent an Urgent - Medical Device Correction Letter dated October 22, 2014, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Our records indicate that you have an affected device. The following page provides additional instructions and actions that will be taken to address this problem. If you need any further information or support concerning this issue, please contact your local Philips representative: 877-468-4861 option 1, then option 2.

Device

Philips MR200 MRI Patient Monitoring System
  • Model / Serial
    Model No. 866120; Lot/ Serial Numbers: US33600065, US33600066, US33600075, US33600077, US33600078, US33600079; US33600080, US33600081, US33600082, US33600083, US33600084, US33600086, US33600087, US33600088, US33600089, US33600090, US33600091, US33600092, US33600093, US33600094.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.
  • Product Description
    Philips Expression MR200 MRI Patient Monitoring System.
  • 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