Recall Z-0213-2012 ยท KGI Densitometer, Bone
Cooper Surgical, Inc.
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 ma
| Date | Nov 18, 2011 (initiated Sep 23, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| 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. |
| Quantity | 184 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992125 | XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 Norland Medical Systems, Inc., Nov 22, 1999 |