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Class 2 Device Recall IMPAX Cardiovascular IMPAX CV12 |
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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
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Product Classification |
System, image processing, radiological - Product Code LLZ
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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
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For Additional Information Contact |
Debbie Huff 864-421-1754
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.
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