Events

Recall of Device Recall Philips Ingenia 1 .5T and Ingenia 3.OT MR systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Electronics North America 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
    75844
  • Event Risk Class
    Class 2
  • Event Number
    Z-0825-2017
  • Event Initiated Date
    2016-12-01
  • Event Date Posted
    2016-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151445
  • 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
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    Possibility that a patient or user may be exposed to a very small level of touch current.
  • Action
    Philips sent an Urgent Field Safety Notice Medical Device Correction letter dated November 2016 to all affected customers. The letter explains the issue and actions planned by Philips. There is no need for action to be taken by customer or user. Customers with questions should contact their local Philips representative Technical Support Line 1-800-722-9377.

Device

Device Recall Philips Ingenia 1 .5T and Ingenia 3.OT MR systems
  • Model / Serial
    781437: 15001, 15002, 15003 781438: 30001, 30002, 30003, 30004, 30005, 30006
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand
  • Product Description
    Ingenia MR-OR; 781437, 781438 || The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA