Cl ll IMPAX 6.5 Client Software

Company:AGFA Corp
Date of Enforcement Report 7/6/2011
Class ll:

PRODUCT
IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be used by a range .

REASON
Software issue that occurs after dictation of a study.

RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp. Greenville, SC, by letter on April 14, 2011.
Manufacturer: Agfa Healthcare Corp., Carlstadt, NJ. Firm initiated recall is ongoing.
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VOLUME OF PRODUCT IN COMMERCE
95 units

DISTRIBUTION
Nationwide

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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