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U.S. Department of Health and Human Services

Class 2 Device Recall Agfa Impax System

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 Class 2 Recall
Agfa Impax System
see related information
Date Posted September 08, 2009
Recall Status1 Open
Recall Number Z-1887-2009
Recall Event ID 52757
Premarket Notification
510(K) Number
K022292 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images. Primary users are radiologists, mammographers, orthopaedists and other trained medical staff.
Code Information Product Version 6.3.1 SU10.
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Jeffery A. Jedlicka
864-421-1815
Manufacturer Reason
for Recall
Measurements are inaccurate on multiple workstations.
FDA Determined
Cause 2
DESIGN: Software Design
Action Agfa Healthcare issued an "URGENT FIELD SAFETY NOTICE" dated July 16, 2009. The notice informed of the problem and provided details to identify potentially compromised data that could result in measurement inaccuracies. A feedback form was provided to be completed and returned to the firm. For further information, contact Agfa Healthcare at 1-773-592-4769.
Quantity in Commerce One unit
Distribution Nationwide Distribution -- IL
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 CORP.
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