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.
FDA Recall Z-1889-2009 · Posted 2009-09-02
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Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2009-06-22
Date Terminated2010-07-22
Product Quantity97 units
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide - IL, PA, TX, Canada, Europe, Asia Pacific and Latin America
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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