FDA Medical Device Recalls (openFDA)
AGFA Corp.: Drystar Mammo. Display of Mammographic images.
- Recall number
- Z-0916-2012
- Recalling firm
- AGFA Corp.
- Product
- Drystar Mammo. Display of Mammographic images.
- Status
- Terminated
- Initiated
- 2010-03-02
- Posted
- not on file
- Terminated
- 2012-02-14
- Reason
- Labeling problem
- 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
- 2 boxes
- Distribution
- Product distributed in Florida.
- Lot, serial or model codes
- ABC Code: EWCAK, size 8x10 inch Manufacturing lot: Emulsion Number: 36760074, cutting plan: B1AW1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWZ
- 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