Z-0035-2014Class II

IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System...

Name: Z-0035-2014 IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System...
Creator: AGFA Corp.
Published: 2013-09-19
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2013-09-19 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS) on 2013-09-19. FDA classified it as Class II and gives the reason as "System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels". 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-0035-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-19
Posted: 2013-10-21
Terminated: 2013-10-24
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Product code: LLZ System, Image Processing, Radiological
Reason for recall: System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: An "URGENT FIELD SAFETY NOTICE" letter was sent via email to the consignees on 9/19/2013, Acknowledgement, via FAX-Back or email, that the information was received and understood has been requested from the consignees. The letter specifically describes the safety alert for the device, informs consignees of the problem and recommends the upgrades for IMPAX and Oracle.
Quantity in commerce: 4
Distribution: Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0035-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0035-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-21

Product code LLZ

K071297Class IIImpax Se Sigmacom Client (Pacs Workstation)Agfa Healthcare Corp. / cleared 2007-06-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)