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FDA Medical Device Recalls (openFDA)

AGFA Corp.: CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).

Recall number
Z-0219-2007
Recalling firm
AGFA Corp.
Product
CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).
Status
Terminated
Initiated
2006-09-01
Posted
2006-11-28
Terminated
2008-04-24
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.
Root cause
Other
Action
A Service Bulletin to address the issues was created on 09/01/2006. Customers were notified of the plans to upgrade via telephone and email on 10/13/2006.
Quantity
178 units
Distribution
Nationwide
Lot, serial or model codes
NX Workstation Software is sold in the following packages: 60+0026406, 60+00026407, 60+00026408, 60+00026857, 60+00026858, 60+00026410, ES885. Software versions: NX 1.0.2402 and NX 1.0.2405
510(k) numbers
not on file
PMA numbers
not on file
Product code
MBQ
Firm FEI
3001236302
Firm city
Greenville
Firm state
SC
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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