Reported Nov 25, 2015 · Terminated
IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic…
AGFA Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AGFA Healthcare Corp. · 10 S Academy St · Greenville, SC · 29601-2632
Is this the product you have?
- 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.
- Lot codes and dates
- Model # L9M2100
- Amount recalled
- 19
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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