Events

Recall of Device Recall iCAT Classic (XRay Tube head and Power Supply)

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
    57583
  • Event Risk Class
    Class 2
  • Event Number
    Z-3018-2011
  • Event Initiated Date
    2010-12-15
  • Event Date Posted
    2011-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96704
  • 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
    Recalling firm received a customer complaint regarding a defective x-ray tube head and power supply.
  • Action
    The firm, Imaging Sciences, sent an "Urgent Medical Device Field Correction" letter dated December 15, 2011 via first class USPS to its customer. The letter noted the product and described the problem and action to be taken. The customer was instructed to complete and return the ACKNOWLEDGEMENT FORM via fax to 215-997-5665 or email: darin.oppenheimer@imagingsciences.com. Imaging Sciences stated in the letter that an X-ray tube head and power supply will be provided and installed by one of their technicians. Should you have any questions regarding this information, call 215-622-1545.

Device

Device Recall iCAT Classic (XRay Tube head and Power Supply)
  • Model / Serial
    Part number 9140-0035 (Tube head) and 9140-1001 (Power Supply)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    X-ray tube and power supply were distributed to one consignee: Dr. Alan D'Allessandro, 2500 W. Higgins Road, Suite 665, Hoffman Estates, IL 60169
  • Product Description
    i-CAT Classic (X-Ray Tube head and Power Supply) || X-Ray imaging device that constructs a three dimensional model from images taken during a rotational X-Ray sequence. Intended to be used whenever a dentist, oral surgeon or other physician needs 3D information of high contrast objects.
  • 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