FDA Medical Device Recalls (openFDA)
AGFA Corp.: IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. The suite is comprised of modular software that runs on industry standard personal computers and servers, utilizing Windows 2000/2003/XP operating systems. Image data storage/display utilizes DICO< (Digital Imaging and Communications in Medicine) data primarily from independent medical devices.
- Recall number
- Z-1435-2011
- Recalling firm
- AGFA Corp.
- Product
- IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. The suite is comprised of modular software that runs on industry standard personal computers and servers, utilizing Windows 2000/2003/XP operating systems. Image data storage/display utilizes DICO< (Digital Imaging and Communications in Medicine) data primarily from independent medical devices.
- Status
- Terminated
- Initiated
- 2009-04-15
- Posted
- 2011-02-25
- Terminated
- 2011-10-13
- Reason
- User could modify a measurement's units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM.
- Root cause
- Other
- Action
- The firm, Agfa Healthcare, sent individual letters dating from April 15, 2009 to August 26, 2009, to the customers. The letters described the product, problem and actions to be taken. Agfa provided the affected customer with a complete list of their impacted patients and the measurements. Agfa also scheduled unit corrections with their customers and received acknowledgement of the letters at the time of scheduling the unit corrections. Service Bulletin DIS026.09E was issued January 2009 to inform users that Agfa will no longer allow customers to request unit changes for measurements that have formulas. Note: Technical Support ran diagnostic scripts for each customer and documented in GSC cases for each consignee/customer. If you have any questions, contact Agfa Healthcare at (949) 830-4959.
- Quantity
- 6 devices
- Distribution
- Nationwide distribution: USA including states of: IL, MT, NY, OR and SC.
- Lot, serial or model codes
- Software Versions: RM 2.03, 2.04 & 2.06
- 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