• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX CV Reporting NonInvasive Vascular (NIV)/Results Management (RM) NIV

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
IMPAX CV Reporting NonInvasive Vascular (NIV)/Results Management (RM) NIV
see related information
Date Posted July 24, 2012
Recall Status1 Terminated on October 29, 2013
Recall Number Z-2069-2012
Recall Event ID 62534
Premarket Notification
510(K) Number
K050228 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.
Code Information Software Version: RM 2.03 to 2.08, NIV 1.0
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
When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action AGFA Healthcare sent an Urgent Field Safety Notice dated July 10, 2012, to all affected consignees indicating that a representative from the IMPAX CV product management or professional services team would be contacting them to perform a review of their system. For questions customers were asked to call 401-604-2180. For questions regarding this recall call 864-421-1754.
Quantity in Commerce 6
Distribution Nationwide Distribution including IN, SC, OH, TX
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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.
-
-