Nov

2006

Class II AGFA Corp

Company:AGFA Corp.,
Date of Enforcement Report:11/29/2006
Class:ll

PRODUCT
CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405), Recall # Z-0219-2007

REASON
Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web.

CODE
60+0026406, 60+00026407, 60+00026408, 60+00026857, 60+00026858, 60+00026410, ES885. Software versions: NX 1.0.2402 and NX 1.0.2405

RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by service bulletin on September 1, 2006 and by telephone and email on October 13, 2006.
Manufacturer: AGFC Corp., Mortsel, Belgium. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
178 units

DISTRIBUTION
Nationwide

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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Class II AGFA Corp

Amy Sellers

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