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U.S. Department of Health and Human Services

Class 2 Device Recall Agfa Healthcare Corp. NX 2008 Central Monitoring System

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 Class 2 Recall
Agfa Healthcare Corp. NX 2008 Central Monitoring System
see related information
Date Posted September 02, 2009
Recall Status1 Terminated on July 22, 2010
Recall Number Z-1889-2009
Recall Event ID 52679
Premarket Notification
510(K) Number
K090672 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa's Computed Radiography Systems with NX Workstations are intended for use in providing diagnostic quality images to aid the physician with diagnosis.
Code Information NX Software versions: 2.0. 7000, 3.0.7000, 2.0.8000 and 3.0.8000.
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Jeffery A. Jedlicka
864-421-1815
Manufacturer Reason
for Recall
After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system.
FDA Determined
Cause 2
DESIGN: Software Design
Action An "Urgent Safety Notice" was sent to all potentially affected sites on/about June 22, 2009 to make them aware of the issue. A FAX Back form is requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. A software service update to solve this issue is expected to be released by August 15, 2009. A Mandatory Service Bulletin will be deployed to correct the problem in the software. If you have questions, please contact Agfa Healthcare at 1-800-581-2432 prompts 1, 3 and then 2 for CR Support.
Quantity in Commerce 97 units
Distribution Worldwide - IL, PA, TX, Canada, Europe, Asia Pacific and Latin America
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = AGFA HEALTHCARE N.V.
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