Events

Recall of Device Recall DEXIS Imaging Suite

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Imaging Sciences International, LLC.

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
    62830
  • Event Risk Class
    Class 2
  • Event Number
    Z-2463-2012
  • Event Initiated Date
    2012-07-30
  • Event Date Posted
    2012-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111796
  • 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, image processing, radiological - Product Code LLZ
  • Reason
    A condition can occur during renumbering of the patient database using the dexcopy feature. when renumbering is being performed using the dexcopy feature and multiple patients with an identical name are present, the software will assign all subsequent records to the first patient record, resulting in mixed patient records. in order for this problem to occur several conditions need to be met: 1).
  • Action
    DEXIS sent a Medical Device Corrective Action letter dated July 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. An Acknowledgement Form was included with the notification that is to be returned by the consignee to the recalling firm. Customers were instructed to call DEXIS Technical Support at 888-883-3947 as soon as possible to have Technical Support review and potentially correct any issues that may have resulted from its use. To request a free-of-charge upgrade kit, customers should email a request to orders@dexis.com. For questions regarding this recall call 215-997-5666,

Device

Device Recall DEXIS Imaging Suite
  • Model / Serial
    Catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including Washington, DC, AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and the country of Canada.
  • Product Description
    DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 || Radiological Image Processing System
  • Manufacturer
    Imaging Sciences International, LLC

Manufacturer

Imaging Sciences International, LLC
  • Manufacturer Address
    Imaging Sciences International, LLC, 1910 North Penn Rd, Hatfield PA 19440-1960
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA