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.
- Company
- Agfa Corp.
- Recall Initiated
- June 22, 2009
- Posted
- September 2, 2009
- Terminated
- July 22, 2010
- Recall Number
- Z-1889-2009
- Quantity
- 97 units
- Firm Location
- Greenville, SC
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.
Distribution
Worldwide - IL, PA, TX, Canada, Europe, Asia Pacific and Latin America
Lot / Code Info
NX Software versions: 2.0. 7000, 3.0.7000, 2.0.8000 and 3.0.8000.
Root Cause
Software design
Action Taken
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.