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.
FDA Recall Z-2180-2008 · Posted 2008-09-04
Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-06-04
Date Terminated2009-10-09
Product Quantity371 units
Reason for Recall
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.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
U.S., 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.