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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognitio

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  Class 2 Device Recall IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognitio see related information
Date Initiated by Firm April 30, 2014
Date Posted May 27, 2014
Recall Status1 Terminated 3 on September 18, 2014
Recall Number Z-1662-2014
Recall Event ID 68211
510(K)Number K050228  
Product Classification System, image processing, radiological - Product Code LLZ
Product IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
Code Information Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - 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		 Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
FDA Determined
Cause 2		 Software design
Action AGFA Healthcare sent an URGENT FIELD SAFETY NOTICE LETTER dated April 30, 2014, to the consignee describing the problem that had occurred, the actions being taken by Agfa and the actions Agfa has required the site to perform. As part of the correction Agfa requires the consignee to review the affected reports to confirm that the data is correct. If errors are found the consignee will need to correct the data. The consignee was asked to acknowledge, via FAX-Back to 864-421-1664 or email, that the information was received and understood by the consignee. For questions the consignee was instructed to contact their local Agfa HealthCare organization at 877-777-2432. For questions regarding this recall call 864-421-1754.
Quantity in Commerce One
Distribution Distribution to SC only
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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