Events

Recall of Trolley for Intera/NT MRI System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems Sales & Service Region No. America.

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
    29229
  • Event Risk Class
    Class 2
  • Event Number
    Z-1028-04
  • Event Initiated Date
    2004-05-13
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33365
  • 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
    Patient and mri tabletop may fall if the tabletop is not positioned correctly on the mri trolley.
  • Action
    The firm sent a letter via certified mail to all customers on May 13, 2004 instructing their customers to check the position of the tabletop to ensure it is correctly aligned on the trolley. The firm is implementing a design modification beginning May 13, 2004. A field service engineer will contact the customers to arrange for installation of the retrofit for the trolley.

Device

Trolley for Intera/NT MRI System
  • Model / Serial
    The firm uses site numbers instead of serial numbers: Site Numbers: 105313, 104340, 105929, 84700, 103811, 103904, 504899, 102157, 103592, 85500, 87355, 86404, 103247, 87604, 505682, X1595, 101595, 87062, 103215, 86012, 103620, 101070, 104897, 105486, 83306, 86184, 100826, 84899, 100629, 87527, 84820, 100786, 86085, X1649, 504412, 504741, 87365, 102786, 104886, 103688, 86570, 102095, 103665, 100459, 103611, 102353, 104102, 100462, 103101, 103540, 85158, 103450, 102671, 102896, 102698, 83080, 103782.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to hospitals and medical centers nationwide.
  • Product Description
    Trolley for Intera/NT MRI System
  • Manufacturer
    Philips Medical Systems Sales & Service Region No. America

Manufacturer

Philips Medical Systems Sales & Service Region No. America
  • Manufacturer Address
    Philips Medical Systems Sales & Service Region No. America, 22100 Bothell Everett Highway, Bothell WA 98041
  • Source
    USFDA