Z-0788-06

Mamoray HDR-C PLUS Mammography film

Name: Z-0788-06 Mamoray HDR-C PLUS Mammography film
Creator: AGFA Corp.
Published: 2006-02-16
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2006-02-16 / Terminated

FDA source

AGFA Corp. began a recall of Mamoray HDR-C PLUS Mammography film on 2006-02-16. The reason FDA records is "The film was incorrectly notched". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0788-06
Status: Terminated
Initiated: 2006-02-16
Posted: 2006-04-22
Terminated: 2006-06-23
Recalling firm: AGFA Healthcare Corp.
Product: Mamoray HDR-C PLUS Mammography film
Product code: IWZ Film, Radiographic
Reason for recall: The film was incorrectly notched.
FDA root cause: Other
Action: Consignees were notified by letter on/about 02/16/2006.
Quantity in commerce: 16523 units
Distribution: Nationwide
Product codes and lots: Product Code: EMLOV, Batch 37300052

Product code IWZ

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)