FDA Medical Device Recalls (openFDA)
AGFA Corp.: IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images.
- Recall number
- Z-1256-06
- Recalling firm
- AGFA Corp.
- Product
- IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images.
- Status
- Terminated
- Initiated
- 2006-06-30
- Posted
- 2006-07-27
- Terminated
- 2006-09-05
- Reason
- Possible corrupted image appearing after System Start.
- Root cause
- Other
- Action
- On 06/30/2006 Agfa upgraded the Software on the installed units using a Mandatory Service Bulletin DD+DIS225.06E.
- Quantity
- 2 units
- Distribution
- NY
- Lot, serial or model codes
- All Impax 4.5 sites running Solaris 9 (Sun OS 5.9) that do not have Sun Patch ID 118305-08 installed.
- 510(k) numbers
- ["K022292"]
- PMA numbers
- not on file
- Product code
- LLZ
- 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