Z-1256-06

IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images

Name: Z-1256-06 IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images
Creator: AGFA Corp.
Published: 2006-06-30
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2006-06-30 / Terminated

FDA source

AGFA Corp. began a recall of IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images on 2006-06-30. The reason FDA records is "Possible corrupted image appearing after System Start". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1256-06
Status: Terminated
Initiated: 2006-06-30
Posted: 2006-07-27
Terminated: 2006-09-05
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Possible corrupted image appearing after System Start.
FDA root cause: Other
Action: On 06/30/2006 Agfa upgraded the Software on the installed units using a Mandatory Service Bulletin DD+DIS225.06E.
Quantity in commerce: 2 units
Distribution: NY
Product codes and lots: All Impax 4.5 sites running Solaris 9 (Sun OS 5.9) that do not have Sun Patch ID 118305-08 installed.

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