FDA Medical Device Recalls (openFDA)
AGFA Corp.: IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
- Recall number
- Z-0033-2007
- Recalling firm
- AGFA Corp.
- Product
- IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
- Status
- Terminated
- Initiated
- 2006-08-08
- Posted
- 2006-10-12
- Terminated
- 2007-02-20
- Reason
- Failed CAD displayed as 'No Findings'
- Root cause
- Other
- Action
- Consignees were notified by letter on/about 08/08/2006.
- Quantity
- 20 Impax 5.2 Mammo licenses were issued domestically.
- Distribution
- Nationwide.
- Lot, serial or model codes
- Diagnostic Workstation/Impax 5.2/with CAD Capability/Flat Panel 60+00024433, Diagnostic Workstation/Impax 5.2/with CAD Capability/CRT: 60+00024432 and Clinical Review Station/Impax 5.2/with CAD Capability/Flat Panel: 60+00024438. Software version Impax 5.2.2 sites using CAD.
- 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