09

Mar

2011

Cl ll AGFA IMPAX CV Results Manager

0

Company: AGFA Corp.
Date of Enforcement Report 3/9/2011
Class ll:

PRODUCT
IMPAX CV Results Manager/Results Manager Administration Tool. The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. The suite is comprised of modular software that runs on industry standard personal computers and servers, utilizing Windows 2000/2003/XP operating systems. Image data storage/display utilizes DICO< (Digital Imaging and Communications in Medicine) data primarily from independent medical devices. Recall # Z-1435-2011

REASON
User could modify a measurement’s units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM.

RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp. Greenville, SC, by letters dating from April 15, 2009 to August 26, 2009.
Manufacturer: AGFA healthcare Corp., Westerly, RI. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6 units

DISTRIBUTION
IL, MT, NY, OR, SC

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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