Aug

2012

Cl ll AGFA IMPAC CV DICOMStore

Company:AGFA Corp. .
Date of Enforcement Report 8/29/12
Class ll:

PRODUCT

AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device .Recall Number Z-2252-2012

REASON
Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa’s Medical Image Storage Devices – Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS).

RECALLING FIRM/MANUFACTURER
AGFA Corp. Greenville, SC on 8/9/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
535 units

DISTRIBUTION
Nationwide, Virgin Islands 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 AGFA IMPAC CV DICOMStore

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