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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 January 12, 2012
Recall Number Z-0352-06
Recall Event ID 34087
510(K)Number K974597  
Product Classification System, X-Ray, Stationary - Product Code KPR
Product ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line.
Code Information Serial Numbers: ADC Solo: Units with Serial numbers les than 4748, Initia CR1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP100: all serial numbers are considered affected unless they have been upgraded to software version SOL_2205 or later.
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Ray B. Myers Ph.D
864-864-1827
Manufacturer Reason
for Recall		 Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on/about December 1, 2005.
Quantity in Commerce 1059 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 = KPR and Original Applicant = BAYER CORP., AGFA DIV.
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