FDA Medical Device Recalls (openFDA)
AGFA Corp.: AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
- Recall number
- Z-2252-2012
- Recalling firm
- AGFA Corp.
- Product
- AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
- Status
- Terminated
- Initiated
- 2012-08-09
- Posted
- 2012-08-22
- Terminated
- 2015-12-08
- Reason
- Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa's Medical Image Storage Devices - Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS).
- Root cause
- Process design
- Action
- On 8/9/2012 AGFA Healthcare issued an "URGENT FIELD SAFETY NOTICE" letter to consignees. This letter describes the problem and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood was also required from the consignees
- Quantity
- 535
- Distribution
- USA Nationwide, Virgin Islands and Canada
- Lot, serial or model codes
- All software versions of DICOMstore in combination with Media Purge Daemon (MPD) or Cardiovascular Purge Services (CPS).
- 510(k) numbers
- ["K050228"]
- 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