Jun

2014

Cl II IMPAX CV Pediatric Echo Reporting

Company: NAGFA Corp.
Date of Enforcement Report:6/4/2014
Class lI:

PRODUCT

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.
Recall Number Z-1662-2014

REASON
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.

RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC on 4/30/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
One

DISTRIBUTION
Distribution to SC only

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II IMPAX CV Pediatric Echo Reporting

Amy Sellers

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