Events

Recall of Device Recall IntelliSpace Portal,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) Inc.

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
    61367
  • Event Risk Class
    Class 2
  • Event Number
    Z-1337-2012
  • Event Initiated Date
    2012-02-22
  • Event Date Posted
    2012-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107923
  • 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, tomography, computed, emission - Product Code KPS
  • Reason
    A number of non-conformances were logged for intellispace portal running software version 4.0 during in-house random verification testing. when loading a study to review, after failing to load it through add to running application the analysis application is not being closed and different (1st loaded study) patient appears in analysis (cca).
  • Action
    Philips Healthcare sent an Urgent Medical Device Correction letter dated February 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. Customers were asked to retain a copy with the equipment instruction for use. For any further information or support customers should contact their local Philips representative or local Philips Healthcare office. Customers in North America and Canada should contact the Customer Care Solutions Center at 1-800-722-9377, option 5. For questions regarding this recall call 440-483-7000.

Device

Device Recall IntelliSpace Portal,
  • Model / Serial
    M/N 881001, Serial Numbers: 30001, 30003, 30004, 30007, 30008, 30016, 30018, 30019, 35006, 79932, 79933, 79935, 79936, 79939, 79940, 80071, 80425, 80891, 80910, 80914, 80979, 80980, 80994, 81004, 81008, 81015, 81026-81028, 81031, 81035, 81063, 81065, 81079, 81081, 81085, 81089, 81119, 81127, 81129, 81130, 81132, 81133, 81147, 81150, 81157, 81161, 81163-81165, 81169, 81172, 82004, 82006-82009, 82011, 82015-82018, 82020, 82021, 82023-82030, 85006-85011, 85025-, 5027, 85029, 85041-85043, 85046, 85049, 85053, 85067 & 85068.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, FL, GA, IO, IN, MI, NJ, NY, OH, OK, OR, PA, SC, TN, TX & WA and the countries of Australia, Canada, China, Czech Republic, France, Germany, India, Indonesia, Israel, Italy, Poland, Spain, Sweden, Switzerland & United Kingdom
  • Product Description
    IntelliSpace Portal, M/N 881001, IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin- client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA