Mar

2011

Cl ll IMPAX Cardiovascular Review Station

Company: AGFA Corp.
Date of Enforcement Report 3/30/2011
Class ll:

PRODUCT
Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting. Recall # Z-1434-2011

REASON
Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports.

RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter dated January 27, 2011.
Manufacturer: AGFA healthcare Corp., Westerly, RI. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
107 units

DISTRIBUTION
Nationwide and Canada

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 ll IMPAX Cardiovascular Review Station

Amy Sellers

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