FDA Medical Device Recalls (openFDA)
AGFA Corp.: IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images.
- Recall number
- Z-1245-2008
- Recalling firm
- AGFA Corp.
- Product
- IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images.
- Status
- Terminated
- Initiated
- 2007-06-28
- Posted
- 2008-09-11
- Terminated
- 2011-03-03
- Reason
- Text and Images may not be synchronized.
- Root cause
- Software design
- Action
- AGFA notified all consignees via registered letter on/about 06/28/2007 informing them of the potential problem and requesting the accounts ensure the visual synchronization indicators in the Text and Image Areas are used to verify the synchronization status of the Text and Image Areas. A FAX Back form was requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. A Mandatory Service Bulletin was deployed to correct the problem in the software.
- Quantity
- 154 units
- Distribution
- U.S. Nationwide and Canada
- Lot, serial or model codes
- Software version IMPAX 6.2.1
- 510(k) numbers
- ["K040555","K050751"]
- 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