FDA Medical Device Recalls (openFDA)
AGFA Corp.: IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
- Recall number
- Z-0035-2014
- Recalling firm
- AGFA Corp.
- Product
- IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
- Status
- Terminated
- Initiated
- 2013-09-19
- Posted
- 2013-10-21
- Terminated
- 2013-10-24
- Reason
- System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.
- Root cause
- Software in the Use Environment
- Action
- An "URGENT FIELD SAFETY NOTICE" letter was sent via email to the consignees on 9/19/2013, Acknowledgement, via FAX-Back or email, that the information was received and understood has been requested from the consignees. The letter specifically describes the safety alert for the device, informs consignees of the problem and recommends the upgrades for IMPAX and Oracle.
- Quantity
- 4
- Distribution
- Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.
- Lot, serial or model codes
- N/A
- 510(k) numbers
- ["K071297"]
- 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