Events

Recall of Vista 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 North America Co. Phillips.

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
    49489
  • Event Risk Class
    Class 2
  • Event Number
    Z-2430-2010
  • Event Initiated Date
    2008-09-19
  • Event Date Posted
    2010-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73603
  • 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
    Water may collect and freeze in the vent pipe. this can rupture the magnet vessel during a cryogen transfer, and release helium into the mri suite.
  • Action
    Philips issued an Urgent Correction letter dated 09/19/2008 to their consignees, identifying the reason for the recall and the affected products. The firm issued the Field Change Order (FCO) 78100232. Field service engineers will visit each consignee and conduct an inspection of the magnets venting system of Edge, Vista, Eclipse, Polaris, Infinion, and Panorama 0.6T MRI systems. The consignees should contact the Philips Call Center at 1-800-772-9377, #5 #2 and reference "FCO 78100232".

Device

Vista MRI System
  • Model / Serial
    16 units are identified as Site Numbers:  200244, 200927, 204515, 209679, 223263, 32755, 36672, 500090, 500097, 71457, 74287, 75125, 75265, 77211, 78442 and 78451.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: USA., including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. There is no distribution to foreign consignees.
  • Product Description
    Vista Nuclear Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A..
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA