FDA Medical Device Recalls (openFDA)
AGFA Corp.: DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.
- Recall number
- Z-0464-2011
- Recalling firm
- AGFA Corp.
- Product
- DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.
- Status
- Terminated
- Initiated
- 2010-10-08
- Posted
- 2010-11-26
- Terminated
- 2010-12-30
- Reason
- Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee.
- Root cause
- Other
- Action
- Agfa halted Installation of the incorrect unit, and the unit was sent to Agfa warehouse in Carlstadt, NJ, where it is being held in quarantine for export.
- Quantity
- One unit
- Distribution
- Nationside Distribution: to NJ.
- Lot, serial or model codes
- Model 5170/100
- 510(k) numbers
- ["K092238"]
- PMA numbers
- not on file
- Product code
- MQB
- 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