Company: Applicare Medical Imaging
Date of Enforcement Report: 9/12/01
Class: II
RECALL NUMBER, PRODUCT AND CODE:
Z-0857-1/Z-0858-1
RadWorks Software Version 5.1 with Software Patch 5 or 7, and RadWorks WebViewer Software Verion 5.1 running on RadWorks 5.1 Software Patch 5 or 7; picture archival and communications system; Applicare Medical Imaging B.V., Zeist, The Netherlands Codes: RadWorks Software Version 5.1 with Software Patch 5 or 7and RadWorks Webviewer Software 5.1 running on RadWorks 5.1 Software Patch 5 or 7
REASON:
Software anomaly causes image to be associated with wrong DICOM header
MANUFACTURER/RECALLING FIRM:
Applicare Medical Imaging, B.V. ZEIST,
RECALLED BY:
GE Medical Systems Information Technologies, Mt. Prospect, IL , by telephone on 3/8/01,and .by letters dated 3/6/01 and flagged “URGENT Safety Alert”.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide through nine distributors in New Jersey, Wisconsin, Nebraska, Texas, Illinois, Colorado and Ohio.
QUANTITY:
3319 RadWorks 5.1 and 56 RadWorks WebViewer 5.1 licenses
