Z-1889-2009

NX 2008 Central Monitoring System (CMS)

Name: Z-1889-2009 NX 2008 Central Monitoring System (CMS)
Creator: AGFA Corp.
Published: 2009-06-22
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2009-06-22 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa's Computed Radiography Systems with NX Workstations are intended for use in providing... on 2009-06-22. The reason FDA records is "After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1889-2009
Status: Terminated
Initiated: 2009-06-22
Posted: 2009-09-02
Terminated: 2010-07-22
Recalling firm: AGFA Healthcare Corp.
Product: NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa's Computed Radiography Systems with NX Workstations are intended for use in providing diagnostic quality images to aid the physician with diagnosis.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system.
Root cause tag: software
FDA root cause: Software design
Action: An "Urgent Safety Notice" was sent to all potentially affected sites on/about June 22, 2009 to make them aware of the issue. A FAX Back form is requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. A software service update to solve this issue is expected to be released by August 15, 2009. A Mandatory Service Bulletin will be deployed to correct the problem in the software. If you have questions, please contact Agfa Healthcare at 1-800-581-2432 prompts 1, 3 and then 2 for CR Support.
Quantity in commerce: 97 units
Distribution: Worldwide - IL, PA, TX, Canada, Europe, Asia Pacific and Latin America
Product codes and lots: NX Software versions: 2.0. 7000, 3.0.7000, 2.0.8000 and 3.0.8000.

Product code LLZ

K090672Class IIAgfa Computed Radiography Systems with Nx WorkstationsAgfa Healthcare N.V. / cleared 2009-05-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)