Events

Recall of Hologic Fluoroscan Mini CArm Model with InSight FD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hologic, 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
    63180
  • Event Risk Class
    Class 2
  • Event Number
    Z-2453-2012
  • Event Initiated Date
    2012-09-14
  • Event Date Posted
    2012-09-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112852
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • Reason
    Fluoroscan mini c-arm models -insight2, version 4.0 and 4.0.1 - dicom images stored in pacs may be flipped 180¿around vertical axis. insight fd, version 5.0.1 and 5.0.2 - dicom images stored in pacs may be lipped 180¿ around vertical axis as well as 180¿ around a horizontal axis.
  • Action
    Hologic issued an Urgent: Medical Device recall letter dated September 14, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Halogen corrected the anomaly and they provided the customer with the revised version of the software. Customers were asked to update their systems in accordance with the instructions provided with the software included with the letter. Customers were also asked to complete the attached acknowledgement form and fax or mail it to the firm at their earliest convenience. For any questions customers were instructed to call Hologic's Help Desk at 1-800-321-4659. For questions regarding this recall call 781-999-7300.

Device

Hologic Fluoroscan Mini CArm Model with InSight FD
  • Model / Serial
    Software version 5.0.1and 5.0.2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia,Belgium, Canada, China, Germany, Ecuador, Spain, France, Great Britain, Greece, Hong Kong, Italy, Japan Korea, Lithuvania, Neherlands, qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan, South Africa, and Switzerland.
  • Product Description
    Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 || The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
  • Manufacturer
    Hologic, Inc.

Manufacturer

Hologic, Inc.
  • Manufacturer Address
    Hologic, Inc., 35 Crosby Dr, Bedford MA 01730-1450
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA