Events

Recall of DICOM Option for the Norland Illuminatus Software Revs

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cooper Surgical, 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
    60101
  • Event Risk Class
    Class 2
  • Event Number
    Z-0213-2012
  • Event Initiated Date
    2011-09-23
  • Event Date Posted
    2011-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104432
  • 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
    Densitometer, bone - Product Code KGI
  • Reason
    The dicom software, norland illuminatus dxa software with the dicom option (part number 434a133) version 4.2.0 through 4.3.1, which is installed on the xr-600, xr-800, xr-46 and excell dxa bone densitometers, could lead to improper patient information getting into a previous patient's record.
  • Action
    The firm, CooperSurgical, sent a "Notice of RECALL-URGENT" letter dated September 23, 1011 to its customers. The letter described the product, "Problem/Situation", and "When can this problem occur?". CooperSurgical will send a new revision of Illuminatus software to the customers once available. If you have any concerns about your existing database of patients, please contact our Norland Technical Support team at (203) 601-5200 Extension 9888 or 9889.

Device

DICOM Option for the Norland Illuminatus Software Revs
  • Model / Serial
    Part Number 434A133 - Revs 4.2.0 through 4.3.1  Scanner S/N Scanner Type 3602 Eclipse 3730 Eclipse 3734 Eclipse 3763 Eclipse 3807 Eclipse 3862 Eclipse 3863 Eclipse 3873 Eclipse 3912 Eclipse 4006 Eclipse 4100 Eclipse 4216 Eclipse 4231 Eclipse 4258 Eclipse 4295 Eclipse 4296 Eclipse 4340 Eclipse 3796 Eclipse  1027 Excell 1028 Excell 1073 Excell 1088 Excell 1115 Excell 1117 Excell 1122 Excell 1124 Excell 1142 Excell 1163 Excell 1180 Excell 1187 Excell 1213 Excell 1296 Excell 1307 Excell 1360 Excell 1372 Excell 1383 Excell 1405 Excell 1437 Excell 1446 Excell 1472 Excell 1483 Excell 1496 Excell 1527 Excell 1601 Excell 1605 Excell 1637 Excell 1644 Excell 1658 Excell 1676 Excell 1679 Excell 1685 Excell 1687 Excell 1735 Excell 1741 Excell 1793 Excell 1807 Excell 1819 Excell 1846 Excell 1878 Excell 1931 Excell 1934 Excell 1938 Excell 1954 Excell 1954 Excell 1971 Excell 1998 Excell 2004 Excell 2005 Excell 2016 Excell 2017 Excell 2027 Excell 2029 Excell 2031 Excell 2032 Excell 2033 Excell 2034 Excell 2035 Excell 6782 XR-36 6914 XR-36 8501 XR-36 6960CE XR-36 8005 XR-46 8017 XR-46 8066 XR-46 8147 XR-46 8148 XR-46 8162 XR-46 8188 XR-46 8216 XR-46 8325 XR-46 8329 XR-46 8331 XR-46 8334 XR-46 8335 XR-46 8511 XR-600 20000 XR-600 20001 XR-600 20002 XR-600 20005 XR-600 20013 XR-600 20018 XR-600 20020 XR-600 20022 XR-600 20023 XR-600 20024 XR-600 20028 XR-600 20032 XR-600 20034 XR-600 20036 XR-600 20047 XR-600 20048 XR-600 20049 XR-600 20051 XR-600 20052 XR-600 20057 XR-600 20059 XR-600 20060 XR-600 20064 XR-600 20067 XR-600 20069 XR-600 20070 XR-600 20073 XR-600 20074 XR-600 20077 XR-600 20078 XR-600 20079 XR-600 20082 XR-600 20085 XR-600 20087 XR-600 20090 XR-600 20094 XR-600 20102 XR-600 20104 XR-600 20108 XR-600 20116 XR-600 20121 XR-600 20133 xr-600 20135 XR-600 20138 XR-600 20140 XR-600 8502 XR-800 8506 XR-800 8514 XR-800 8515 XR-800 8523 XR-800 8524 XR-800 8531 XR-800 8532 XR-800 8533 XR-800 8537 XR-800 8543 XR-800 8547 XR-800 8549 XR-800 8551 XR-800 8552 XR-800 8553 XR-800 8556 XR-800 8558 XR-800 8559 XR-800 8560 XR-800 8561 XR-800 8562 XR-800 8563 XR-800 8565 XR-800 8566 XR-800 8567 XR-800 8569 XR-800 8571 XR-800 8572 XR-800 8577 XR-800 8579 XR-800 8582 XR-800 8583 XR-800 8584 XR-800 8587 XR-800 8588 XR-800 8591 XR-800 8596 XR-800 8597 XR-800 8599 xr-800 8600 xr-800 8604 XR-800 8611 XR-800 8614 XR-800
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AZ, AR, CA, FL, GA, IN, KS, KY, LA, MD, MA, MI, MO, NJ, NY, NC, OK, PA, TN, TX, UT, and WI ; and countries of: ARGENTINA, AUSTRALIA, BELGIUM SPAIN, CANADA, CHINA, DENMARK, EMIRATES, ENGLAND, FRANCE, GERMANY, GREECE, IRELAND, MALTA, POLAND, SAUDI ARABIA, SOUTH KOREA, and TAIWAN.
  • Product Description
    DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometers. || The XR 46 performs DXA scans of the AP Spine, Hip, Forearm, Lateral Spine, and Whole Body, as well as other user selectable sites. It provides BMD (g/cm2), Area (cm2), and BMC (g) values. It compares these values to gender and ethnic matched reference populations and provides T-Score and % young Reference, Z- Score and % age matched, and long term and short term change values. This includes sBMD (mg/cm2). The XR 46 performs soft tissue assessment and provides lean mass, fat mass, percent fat, and total soft tissue values for all scan sites, including Whole Body. The XR 46 includes a Report writer that allows the operator to customize the appearance of their report stand to automate the tedious part of the report. It also allows the user to enter ranges of patient values and the specific statements they want to be printed on their report for each of these ranges. The bone density measurements from the XR 46 can be used as an aid to physicians in determining fracture risk.
  • Manufacturer
    Cooper Surgical, Inc.

Manufacturer

Cooper Surgical, Inc.
  • Manufacturer Address
    Cooper Surgical, Inc., 95 Corporate Dr, Trumbull CT 06611-1350
  • Manufacturer Parent Company (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA