FDA Medical Device Recalls (openFDA)
AGFA Corp.: CR DX-S, Image Intensified Fluoroscopic X-ray system.
- Recall number
- Z-0031-2007
- Recalling firm
- AGFA Corp.
- Product
- CR DX-S, Image Intensified Fluoroscopic X-ray system.
- Status
- Terminated
- Initiated
- 2006-06-28
- Posted
- 2006-10-12
- Terminated
- 2007-05-10
- Reason
- Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.
- Root cause
- Other
- Action
- Consignees were notified by letter on/about 06/28/2006.
- Quantity
- 11 units
- Distribution
- CA, DC, FL, MN, MI, MS, OR.
- Lot, serial or model codes
- Units with Serial number SN1001- SN1179, and SN1181, SN1183 and SN1184; Software versions: STR_1207 and below.
- 510(k) numbers
- ["K050810"]
- 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