Events

Recall of Gyroscan Intera 1.0T & 1.5T

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 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
    26580
  • Event Risk Class
    Class 2
  • Event Number
    Z-1229-03
  • Event Initiated Date
    2002-11-21
  • Event Date Posted
    2003-09-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27925
  • 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 burns from cables near or in contact with the patient during use.
  • Action
    On 11/21/02, the firm provided Field Change Order (FCO) 781 00006 to their field employees. This FCO instructed the field employees to visit the consignees and provide them with the addendums to the Instruction For Use Manual.

Device

Gyroscan Intera 1.0T & 1.5T
  • Model / Serial
    Serial numbers listed under Gyroscan ACS-NT with software versions R6x, R7x, R8x
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed units to hospitals and medical centers throughout the U.S.
  • Product Description
    Gyroscan Intera 1.0T & 1.5T
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 22100 Bothell Everett Highway, Bothell WA 98041
  • Source
    USFDA