Z-2246-2011

IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with...

Name: Z-2246-2011 IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with...
Creator: AGFA Corp.
Published: 2011-04-05
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2011-04-05 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful... on 2011-04-05. The reason FDA records is "Software issue that occurs after dictation of a study". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2246-2011
Status: Terminated
Initiated: 2011-04-05
Posted: 2011-05-24
Terminated: 2011-09-15
Recalling firm: AGFA Healthcare Corp.
Product: 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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software issue that occurs after dictation of a study.
Root cause tag: software
FDA root cause: Other
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.
Quantity in commerce: 95 units
Distribution: Nationwide Distribution -- including states of WI, and SC.
Product codes and lots: 35A2Y000, 35AWO000, 5N2N4004, 5NP9X001, 5NSMY000, 5OHXO000, 5QFWU000, E5KN2002, ETQ55000, EU5P6000, EYMFF000, F8AM4771, L18HH000, L2CEW000, L41KH000, L5N26000, L5N4B000, L5N5D000, L5P6O000, L5PD1000, L6S8E000, L8L5U000, L8VHQ000, L9HGC000, LEFG2504, LVTB7007

Product code LLZ

K022292Class IIImpax Diagnostic Display Station,impax Clinical Review Station,impax for Cardiology Clinical Review Satation,impax OrthoAgfa Corp. / cleared 2002-09-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)