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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm November 18, 2005
Date Posted January 06, 2006
Recall Status1 Terminated 3 on June 30, 2009
Recall Number Z-0353-06
Recall Event ID 34088
510(K)Number K010571  
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x)
Code Information Software versions: ADC QS 2.0, CR QS 3.O.207, CR QS 3.O.210, CR QS 3.0.210SU1, CRQS 3.0.229, Centricity CR Online Processing software 2.x.
Recalling Firm/
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Ray B. Myers Ph.D
Manufacturer Reason
for Recall
Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis.
FDA Determined
Cause 2
Action Consignees will be notified by letter on/about December 1, 2005 and offered upgraded software.
Quantity in Commerce 2630 units
Distribution Nationwide
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 CORP.