AGFA Corp. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
AGFA Corp.
Lot Codes / Batch Numbers
NX Software versions: 2.0. 7000, 3.0.7000, 2.0.8000 and 3.0.8000.
Products Sold
NX Software versions: 2.0. 7000, 3.0.7000, 2.0.8000 and 3.0.8000.
AGFA Corp. is recalling NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa's Computed Radiography Systems due to 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 oc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, PA, TX
Page updated: Jan 10, 2026