• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Agfa Impax System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Agfa Impax Systemsee related information
Date Initiated by FirmJuly 16, 2009
Date PostedSeptember 08, 2009
Recall Status1 Terminated 3 on April 28, 2011
Recall NumberZ-1887-2009
Recall Event ID 52757
510(K)NumberK022292 
Product Classification System, image processing, radiological - Product Code LLZ
ProductAgfa 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 SC 29601-2632
For Additional Information ContactJeffery A. Jedlicka
864-421-1815
Manufacturer Reason
for Recall
Measurements are inaccurate on multiple workstations.
FDA Determined
Cause 2
Software design
ActionAgfa 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 CommerceOne unit
DistributionNationwide Distribution -- IL
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
-
-