Events

Recall of Device Recall Lorad

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lorad, A Division of Hologic.

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
    29764
  • Event Risk Class
    Class 2
  • Event Number
    Z-0148-04
  • Event Initiated Date
    2004-01-14
  • Event Date Posted
    2004-08-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34492
  • 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, Mammographic - Product Code IZH
  • Reason
    System failed to meet the ma's accuracy specfications at low ma's values.
  • Action
    Lorad notified customers/dealers by letter dated January 14, 2004. Sites were advised of the corrected Accuracy labeling.

Device

Device Recall Lorad
  • Model / Serial
    S/N''s :18005960001 to 18010034196
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Lorad MIV Platinum Mammograpgy System
  • Manufacturer
    Lorad, A Division of Hologic

Manufacturer

Lorad, A Division of Hologic
  • Manufacturer Address
    Lorad, A Division of Hologic, 36 Apple Ridge Rd, Danbury CT 06810-7301
  • Source
    USFDA