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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 Recall
IMPAX RIS QDOC 5.8 and higher
see related information
Date Posted February 03, 2014
Recall Status1 Terminated on February 28, 2014
Recall Number Z-0919-2014
Recall Event ID 67275
Premarket Notification
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/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Debbie Huff
864-421-1754
Manufacturer Reason
for Recall
Patient name displayed (printed) on the Patient Report was the wrong patient name.
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 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.
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