Z-1799-2010

DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display...

Name: Z-1799-2010 DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display...
Creator: AGFA Corp.
Published: 2010-04-22
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2010-04-22 / Terminated / root cause: manufacturing process

FDA source

AGFA Corp. began a recall of DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images on 2010-04-22. The reason FDA records is "The RF tags on the white protection sheets of the media stacks were incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1799-2010
Status: Terminated
Initiated: 2010-04-22
Posted: 2010-06-11
Terminated: 2011-02-01
Recalling firm: AGFA Healthcare Corp.
Product: DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The RF tags on the white protection sheets of the media stacks were incorrect.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: AGFA Healthcare issued an "Urgent Safety Notice" dated April 22, 2010 requesting a check of warehouse inventory and a request for a sub-recall, if necessary. All affected product should be returned to the firm for replacement. For further information, contact AGFA Healthcare at 1-877-777-2432.
Quantity in commerce: 180 boxes
Distribution: Worldwide Distribution -- United States (AL, CT, FL, KS, MA, MI, NJ, NM, NY, PA and WV), British Columbia and Guatemala.
Product codes and lots: Lot Number: 36810031 (115 stacks) and Lot Number: 36750062 (65 stacks).

Product code LLZ

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)