Class IIl AGFA Corp.

Company: AGFA Corp.,
Date of Enforcement Report:8/2/2006
Class:lIl

PRODUCT
IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images, Recall # Z-1256-06

REASON
Possible corrupted image appearing after System Start.

CODE
All Impax 4.5 sites running Solaris 9 (Sun OS 5.9) that do not have Sun Patch ID 118305-08 installed

RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC, by firm representative visit for software upgrade, on June 30, 2006. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2 units

DISTRIBUTION
NY

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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