FDA Medical Device Recalls (openFDA)
AGFA Corp.: DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.
- Recall number
- Z-1799-2010
- Recalling firm
- AGFA Corp.
- Product
- DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.
- Status
- Terminated
- Initiated
- 2010-04-22
- Posted
- 2010-06-11
- Terminated
- 2011-02-01
- Reason
- The RF tags on the white protection sheets of the media stacks were incorrect.
- 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
- 180 boxes
- Distribution
- Worldwide Distribution -- United States (AL, CT, FL, KS, MA, MI, NJ, NM, NY, PA and WV), British Columbia and Guatemala.
- Lot, serial or model codes
- Lot Number: 36810031 (115 stacks) and Lot Number: 36750062 (65 stacks).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3001236302
- Firm city
- Greenville
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28