Impax 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all versions. The Impax Systems are Picture Archiving and Communications system (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images.
Hazard
The IMPAX client failed to "refresh" the image area upon receiving a study retrieved from archive. The system also erroneously displays this study retrieved from archive as the "active" study.
What You Should Do
An "Urgent Safety Notice" letter was sent to all the sites using potentially affected units on/about June 4, 2008. Dealers were notified via letter on June 9, 2008. The letter requests that all users be reminded that Agfa recommends the system is configured so that demographic information is not removed from the image viewing area. They will be provided with the appropriate Service Update, based on the current version of IMPAX Client 6.x in use at their site. They were advised to distribute the information within their facility to all those who need to be aware of it. A FAX Back form was 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. Contact AGFA at 1-877-777-2432, prompts 1, 2, 1.
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Products
- Brand
- AGFA Corp.
- UPC
- Catalog Numbers for Impax 6.x Client Software: Radiologist Viewer - R6.0 Concurrent User, Package Code: 60+000250353, Product Code: L8DTC; Breast Imaging Radiologist Viewer - R6.0 Concurrent User, Package Code: 60+00025055, Product Code: L8DGM; Orthopeadic Viewer - R6 Concurrent User, Package Code: 60+00025056, Product Code: L8DEH, L4NVL; Radiologist w/QC Viewer - Concurrent User: Product Code: EW43C; Breast Imaging Radiologist w/QC Viewer - Concurrent User, Product Code: EW44E; Enterprise Viewer - Concurrent License, Product Code: L8DP3; Impax¿ 6 Orthopeadic Center Client Site License, Product Code: EW21Y; Impax¿ 6 Site License (includes client site license above - L8FEQ), Package Code: 60+00025123, and Product Code: L8FEQ.
Units Affected
371 units