FDA Medical Device Recalls (openFDA)
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 number
- Z-1889-2009
- Recalling firm
- AGFA 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.
- Status
- Terminated
- Initiated
- 2009-06-22
- Posted
- 2009-09-02
- Terminated
- 2010-07-22
- Reason
- 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
- 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
- 97 units
- Distribution
- Worldwide - IL, PA, TX, Canada, Europe, Asia Pacific and Latin America
- Lot, serial or model codes
- NX Software versions: 2.0. 7000, 3.0.7000, 2.0.8000 and 3.0.8000.
- 510(k) numbers
- ["K090672"]
- PMA numbers
- not on file
- Product code
- LLZ
- 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