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U.S. Department of Health and Human Services

Class 2 Device Recall CR NX Modality Workstation

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 Class 2 Device Recall CR NX Modality Workstationsee related information
Date Initiated by FirmSeptember 01, 2006
Date PostedNovember 28, 2006
Recall Status1 Terminated 3 on April 24, 2008
Recall NumberZ-0219-2007
Recall Event ID 36635
Product Classification Computed Radiography System - Product Code MBQ
ProductCR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).
Code Information NX Workstation Software is sold in the following packages: 60+0026406, 60+00026407, 60+00026408, 60+00026857, 60+00026858, 60+00026410, ES885. Software versions: NX 1.0.2402 and NX 1.0.2405
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information ContactRay B. Myers Ph.D
864-421-1815
Manufacturer Reason
for Recall		Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web.
FDA Determined
Cause 2		Other
ActionA Service Bulletin to address the issues was created on 09/01/2006. Customers were notified of the plans to upgrade via telephone and email on 10/13/2006.
Quantity in Commerce178 units
DistributionNationwide
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.
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