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U.S. Department of Health and Human Services

Class 2 Device Recall Agfa, CR DXS System

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  Class 2 Device Recall Agfa, CR DXS System see related information
Date Initiated by Firm June 28, 2006
Date Posted October 12, 2006
Recall Status1 Terminated 3 on May 10, 2007
Recall Number Z-0031-2007
Recall Event ID 35994
510(K)Number K050810  
Product Classification Fluoroscopic X-ray system - Product Code MQB
Product CR DX-S, Image Intensified Fluoroscopic X-ray system.
Code Information Units with Serial number SN1001- SN1179, and SN1181, SN1183 and SN1184; Software versions: STR_1207 and below.
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Ray B. Myers Ph.D.
864-421-1806
Manufacturer Reason
for Recall		 Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on/about 06/28/2006.
Quantity in Commerce 11 units
Distribution CA, DC, FL, MN, MI, MS, OR.
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 = MQB and Original Applicant = AGFA CORP.
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