Events

Recall of Device Recall Flex SENSE Body Coil used with the the ACS NT, Intera 1.5T and Achieva 1.5T MR Philips MRI 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
    73333
  • Event Risk Class
    Class 2
  • Event Number
    Z-1024-2016
  • Event Initiated Date
    2015-07-06
  • Event Date Posted
    2016-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143907
  • 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
    Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the qbc. the combined use of the sense coil, high sar level scanning and placement of the cables contrary to instructions for use can lead to patient burns.
  • Action
    On 6/18/2015, the Field Safety Notice / Medical Device Correction Notice was sent to customers via certified mailing. The letter explains the issue and provides user instructions. A sleeve is being developed that will be applied to the cable on the Sense Body Coil 1.5T and provide consistent spacing between the cable and the patient, thereby reducing the chance of RF interaction and heating. This sleeve will be distributed as part of a Field Change Order with reference FCO781 00437 for Sense Body Coils in the installed base and will be installed by the Philips Field Service Engineers.

Device

Device Recall Flex SENSE Body Coil used with the the ACS NT, Intera 1.5T and Achieva 1.5T MR Phi...
  • Model / Serial
    4522 131 5575x 4522 132 1985x 4522 132 7619x 4598 000 5187x 4598 000 5189x 4598 003 59051
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: Nationwide OUS: Canada, Afghanistan Albania Algeria Andorra Argentina Australia Austria Azerbaijan Bahamas Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Burkina Faso Chile China Colombia Columbia Congo, Democratic Costa Rica Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Estonia Ethiopia Finland France Georgia Germany Ghana Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy Japan Jersey Jordan Kazakhstan Kenya Korea, Republic of Kuwait Kyrgyzstan Latvia Lebanon Libya Lithuania Luxembourg Malaysia Malta Martinique Mauritius Mexico Monaco Mongolia Morocco Mozambique Nepal Netherlands New Caledonia New Zealand Norway Oman Pakistan Palestinian territory, occupied Panama Papua New Guinea Peru Philippines Poland Portugal Puerto Rico Romania Russian Federation Rwanda Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sudan Sweden Switzerland Syrian Arab Republic Taiwan Tanzania Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Venezuela Viet Nam Yemen Zimbabwe
  • Product Description
    SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
  • 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