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.
FDA Recall Z-0283-2016 · Posted None
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Recalling FirmAGFA Healthcare Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-09-01
Date Terminated2020-12-15
Product Quantity19
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Distributed in the states of CA, KY, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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