Recall Z-1889-2009 ยท LLZ System, Image Processing, Radiological
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.
| Date | Sep 2, 2009 (initiated Jun 22, 2009) |
| Status | Terminated |
| 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 prompt |
| Quantity | 97 units |
| Distribution | Worldwide - IL, PA, TX, Canada, Europe, Asia Pacific and Latin America |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090672 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS Agfa Healthcare N.V., May 18, 2009 |