FDA Medical Device Recalls (openFDA)
AGFA Corp.: CR DX-S, DX-S, Computed radiography system (Digitizer)
- Recall number
- Z-0855-06
- Recalling firm
- AGFA Corp.
- Product
- CR DX-S, DX-S, Computed radiography system (Digitizer)
- Status
- Terminated
- Initiated
- 2005-11-03
- Posted
- 2006-05-09
- Terminated
- 2006-06-20
- Reason
- Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.
- Root cause
- Other
- Action
- Consignees were notified at the time of upgrading. The software was upgraded on 11/3/2005, 12/19/2005 and 12/28/2005. A Mandatory Service Bulletin, No. 11, explaining the issues was shared with the accounts.
- Quantity
- 3 units
- Distribution
- DC, MS, OR--three states
- Lot, serial or model codes
- CR DX-S: Units with Serial numbers SN1001-SN1079, Software versions: STR1102B 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