FDA Recall Terminated

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.

Recall: Z-2246-2011 · Initiated April 5, 2011

Recall

Recall Number
Z-2246-2011
Event Number
58565
Firm
AGFA Corp.
FEI Number
3001236302
Product Code
LLZ
Status
Terminated
Root Cause
Other
Initiated
April 5, 2011
Posted
May 24, 2011
Terminated
September 15, 2011
Address
10 S Academy St, Greenville, SC, 29601-2632

Description

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.

Reason

Software issue that occurs after dictation of a study.

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.

Distribution

Nationwide Distribution -- including states of WI, and SC.

Quantity

95 units