FDA Medical Device Recalls (openFDA)
AGFA Healthcare Corp.: Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
- Recall number
- Z-2176-2014
- Recalling firm
- AGFA Healthcare Corp.
- Product
- Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
- Status
- Terminated
- Initiated
- 2014-05-13
- Posted
- 2014-08-10
- Terminated
- 2014-08-13
- Reason
- Unit was mislabeled with a factory label showing 32 KW output power.
- Root cause
- Labeling mix-ups
- Action
- Only one customer was affected no customer letter was issued field correction was conducted..
- Quantity
- 1
- Distribution
- US in the state of WV
- Lot, serial or model codes
- Serial Number A5410000042
- 510(k) numbers
- ["K103597"]
- PMA numbers
- not on file
- Product code
- IZL
- 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