Z-1306-2008

IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to...

Name: Z-1306-2008 IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to...
Creator: AGFA Corp.
Published: 2007-12-11
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2007-12-11 / Terminated

FDA source

AGFA Corp. began a recall of IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical imaging data. AGFA Corp., Greenville... on 2007-12-11. The reason FDA records is "Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by AGFA Healthcare". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1306-2008
Status: Terminated
Initiated: 2007-12-11
Posted: 2008-07-01
Terminated: 2010-07-21
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical imaging data. AGFA Corp., Greenville, South Carolina 2960.
Product code: LMD System, Digital Image Communications, Radiological
Reason for recall: Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by AGFA Healthcare.
FDA root cause: Release of Material/Component prior to receiving test results
Action: On 12/11/07, AGFA Healthcare sent out an e-mail to all affected consignees informing them of the situation. The firm also arranged to install the corrected License Key on all affected units of the product.
Quantity in commerce: 12 units
Distribution: Nationwide Distribution - USA, including states of CA, GA, IA and SD.
Product codes and lots: ABC Code EXEGE000

Product code LMD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)