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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX CV 7.8 SU3 OCR Service

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  Class 2 Device Recall IMPAX CV 7.8 SU3 OCR Service see related information
Date Initiated by Firm March 15, 2013
Date Posted April 08, 2013
Recall Status1 Terminated 3 on April 01, 2014
Recall Number Z-1069-2013
Recall Event ID 64654
510(K)Number K050228  
Product Classification System, image processing, radiological - Product Code LLZ
Product IMPAX CV 7.8 SU3 - OCR Service.

The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.
Code Information Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Huff
864-421-1754
Manufacturer Reason
for Recall		 Software design error in IMPAX CV 7.8 SU3
FDA Determined
Cause 2		 Software design
Action AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated March 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to distribute this information within your facility to all individuals who need to be aware of this. Please fax back to (864) 421-1664 that the information was received and understood was requested from the customers. If you have any questions about this matter please contact your local AGFA Healthcare organization, or call (864) 421-1754.
Quantity in Commerce 2
Distribution Distribute in the state of FL and KY
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 = HEARTLAB, INC.
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