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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX RIS QDOC 5.8 and higher

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  Class 2 Device Recall IMPAX RIS QDOC 5.8 and higher see related information
Date Initiated by Firm January 08, 2014
Date Posted February 03, 2014
Recall Status1 Terminated 3 on February 28, 2014
Recall Number Z-0919-2014
Recall Event ID 67275
510(K)Number K111945  
Product Classification System, image processing, radiological - Product Code LLZ
Product IMPAX RIS QDOC 5.8
Code Information Software IMPAX RIS 58 and higher
Recalling Firm/
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Huff
Manufacturer Reason
for Recall
Patient name displayed (printed) on the Patient Report was the wrong patient name.
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action On January 8, 2014, an "URGENT FIELD SAFETY NOTICE" (UFSN) letter was emailed to consignees. The letter described the safety alert and mitigation, including directions to consignees as to how the disable Microsoft Word Background Printing. Acknowledgment via FAX-Back or email, that the information was received and understood was requested from the consignees.
Quantity in Commerce 14
Distribution CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
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 HEALTHCARE N.V.