Events

Recall of Device Recall Beekley Spots Light Image OSpots

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beekley Corporation.

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
    65483
  • Event Risk Class
    Class 3
  • Event Number
    Z-1787-2014
  • Event Initiated Date
    2013-06-19
  • Event Date Posted
    2014-06-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119067
  • 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
    Full field digital,system,x-ray,mammographic - Product Code MUE
  • Reason
    Light image o-spots dispenser mislabeled as soft n' stretchy light image s-spots.
  • Action
    Beekley sent an Urgent Medical Device Recall letters dated June 19, 2013 via FedEx with signature and tracking confirmation. The letter identified the affected product, problem and actions to be taken. Firm requests users to examine inventory, remove and return recalled product. For questions contact Chelsea Fuller, Regulatory Manager at 1-800-233-5539 x 491

Device

Device Recall Beekley Spots Light Image OSpots
  • Model / Serial
    Lot Number: 252.04261301
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA in the states of CA, FL, MA, NC, NY, and PA.
  • Product Description
    Beekley Spots Light Image O-Spots for Mammography || Catalog Number: 252 || Product Usage: To identify raised moles in Mammography
  • Manufacturer
    Beekley Corporation

Manufacturer

Beekley Corporation
  • Manufacturer Address
    Beekley Corporation, 1 Prestige Ln, Bristol CT 06010-7468
  • Manufacturer Parent Company (2017)
    Beekley Corporation
  • Source
    USFDA