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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 Device Recall Agfa Healthcare Corp. NX 2008 Central Monitoring System see related information
Date Initiated by Firm June 22, 2009
Date Posted September 02, 2009
Recall Status1 Terminated 3 on July 22, 2010
Recall Number Z-1889-2009
Recall Event ID 52679
510(K)Number K090672  
Product Classification Solid state x-ray imager (flat panel/digital imager) - 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 SC 29601-2632
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = AGFA HEALTHCARE N.V.
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