Recall of Device Recall 90JAK System, Computed Tomography Xray Scanning System

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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, X-Ray, Tomography, Computed - Product Code JAK
  • Reason
    Software anomaly in the dicom modality worklist. when restoring a patient's images from the optical disk, images from the wrong patient may be displayed.
  • Action
    The firm mailed a ''Product Safety Notification'', dated 3/23/2004, to all users who had DICOM Modality Worklist enabled with a software key. The customers were notified of the problem and were provided instructions as to how to prevent the anomaly from occurring. The notification also informed the users that updated software which corrects the anomaly will be available in the near future and will be installed by the firm''s Field Service Engineers.


  • Model / Serial
    All devices manufactured between January 1996 and June, 2004 were subject to recall.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide and Austria, Italy, Netherlands, Spain, United Kingdom, and Sweden. The units were installed in medical facilities located in the following states within the U.S.: KS, PA, FL, MN, IA, CA, GA, LA, MS, OH, NE, MO, IN, TN, TX, MI, NM, MA, AL and NH;
  • Product Description
    AcQSim X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: Picker, Marconi or Philips.
  • Manufacturer


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