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.
FDA Recall Z-0213-2012 · Posted 2011-11-18
Recalling FirmCooper Surgical, Inc.
Recall StatusTerminated
Product CodeKGI
Date Initiated2011-09-23
Date Terminated2013-04-09
Product Quantity184
Reason for Recall
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.