Company:Cooper Surgical, Inc
Date of Enforcement Report 12/8/11
Class ll:
PRODUCT
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. Part Number 434A133. Recall #Z-0213-2012
REASON
The DICOM Software, could lead to improper patient information getting into a previous patient’s record.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cooper Surgical, Inc., Trumbull, CT, by letter dated September 23, 1011.
Manufacturer: Norland, A CooperSurgical Co., Fort Atkinson, WI. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide and Internationally
