Applicare Medical Imaging ClassII

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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