09
Jul
2008

Cl Il Agfa Corp Impax

0

Company: AGFA Corp
Date of Enforcement Report 7/9/2008
Class:ll

PRODUCT
Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax 5.2 PACs with integrated MediCAD software. The softwares are used to provide digital X-ray images for pre-surgical orthopedic planning, Z-1307-2008

REASON
Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.

RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC, by letters on February 17, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
879 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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