Reported Jun 4, 2014 · Terminated
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service…
AGFA 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 Corp. · 10 S Academy St · Greenville, SC · 29601-2632
Is this the product you have?
- 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.
- Lot codes and dates
- Model L9M21000 - Software versionsIMPAX CV 7.8 SU3/SU4 - OCR Service
- Amount recalled
- One
Where it was sold
Why it was recalled
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
This product could cause temporary or reversible health problems — stop using it.
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