Z-1404-05

Radiomat Lightweight Cassettes

Name: Z-1404-05 Radiomat Lightweight Cassettes
Creator: AGFA Corp.
Published: 2005-01-26
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2005-01-26 / Terminated

FDA source

AGFA Corp. began a recall of Radiomat Lightweight Cassettes on 2005-01-26. The reason FDA records is "Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1404-05
Status: Terminated
Initiated: 2005-01-26
Posted: 2005-08-25
Terminated: 2006-06-20
Recalling firm: AGFA Healthcare Corp.
Product: Radiomat Lightweight Cassettes
Product code: IXA Cassette, Radiographic Film
Reason for recall: Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.
FDA root cause: Other
Action: Consignees were notified by letter on/about 07/29/2005.
Quantity in commerce: 9055 units
Distribution: Nationwide, Canada
Product codes and lots: Product Code: EHYG2, Model: 14x17 Green RE 400 Screens and Cassettes, Product Code: EHYCT, Model: 14x17 Green RE 100 Screens and Cassettes, Product Code: EHX5C, Model: 14x17 Blue RE 800 Screens and Cassettes, Batch number are a combination of 4 letters/numbers xxyy, where xx varies alphabetically form 6N and 6Z and from 7A to &N and yy is a number from 01 through 31. Batch numbers are located both on the cassette shell and on the outer label.

Product code IXA

K023020Class IIAgfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette, Agfa Curix and Lightweight CassetteAgfa Corp. / cleared 2002-09-26

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)