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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX Cardiovascular IMPAX CV12

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  Class 2 Device Recall IMPAX Cardiovascular IMPAX CV12 see related information
Date Initiated by Firm September 01, 2015
Create Date November 17, 2015
Recall Status1 Terminated 3 on December 15, 2020
Recall Number Z-0283-2016
Recall Event ID 72411
510(K)Number K050228  
Product Classification System, image processing, radiological - Product Code LLZ
Product IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
Code Information Model # L9M2100
Recalling Firm/
Manufacturer		 AGFA Healthcare Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Huff
864-421-1754
Manufacturer Reason
for Recall		 Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct.
FDA Determined
Cause 2		 Software design
Action An Urgent Field Safety Notice was sent to accounts via email on 9/1/2015. The letter described the safety alert. Customers were informed of the problem and that Service would be contacting them to arrange a date to deploy the corrective action and install the Service Update at their facility. An acknowledgement was included which was to be faxed back or emailed back to Agfa.
Quantity in Commerce 19
Distribution Distributed in the states of CA, KY, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA and the country of 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 = HEARTLAB, INC.
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