Z-0916-2012

Drystar Mammo. Display of Mammographic images

Name: Z-0916-2012 Drystar Mammo. Display of Mammographic images
Creator: AGFA Corp.
Published: 2010-03-02
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2010-03-02 / Terminated / root cause: labeling and UDI

FDA source

AGFA Corp. began a recall of Drystar Mammo. Display of Mammographic images on 2010-03-02. The reason FDA records is "Labeling problem". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0916-2012
Status: Terminated
Initiated: 2010-03-02
Posted: 2015-06-26
Terminated: 2012-02-14
Recalling firm: AGFA Healthcare Corp.
Product: Drystar Mammo. Display of Mammographic images.
Product code: IWZ Film, Radiographic
Reason for recall: Labeling problem
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm, AGFA Corporation spoke to the customer directly via telephone concerning the mislabeled affected products. The firm also contacted the customer via e-mail on April 13, 2011 explaining the outcome of the customer complaint. Replacement product was sent to the customer.
Quantity in commerce: 2 boxes
Distribution: Product distributed in Florida.
Product codes and lots: ABC Code: EWCAK, size 8x10 inch Manufacturing lot: Emulsion Number: 36760074, cutting plan: B1AW1

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)