22
Dec
2011

Cl ll IMPAX CardioVascular (CV) Admin Tool

0

Company:AGFA Corp.
Date of Enforcement Report 12/21/11
Class ll:

PRODUCT
IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. Recall # Z-0272-2012

REASON
Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it.

RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter on June 6, 2011.
Manufacturer: AGFA HealthCare Corp., Westerly, RI. FDA initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
323 units

DISTRIBUTION
Nationwide and Canada

About the author

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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