IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be used by a range of users on any appropriate, networked workstation they have access to.
FDA Recall Z-2246-2011 · Posted 2011-05-24
Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-04-05
Date Terminated2011-09-15
Product Quantity95 units
Reason for Recall
Software issue that occurs after dictation of a study.
Firm Action
Agfa Corp. sent an "URGENT SAFETY NOTICE" customer letter via Agfa email to customers on 4/14/2011, along with a "URGENT SAFETY NOTICE FEEDBACK FORM," The letter identified the product , the problem, and the action to be taken by the customer.
It was discovered a software issue in the IMPAX 6.5. The upgrade has already been released to address the software problem.
Customers were instructed to fax back the feedback form as soon as possible to (864) 421-1664.
If you have any questions, please contact your local Agfa Healthcare organization.
Root Cause
Other
Distribution Pattern
Nationwide Distribution -- including states of WI, and SC.
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.