Z-1435-2011

IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular suite is a...

Name: Z-1435-2011 IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular suite is a...
Creator: AGFA Corp.
Published: 2009-04-15
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2009-04-15 / Terminated

FDA source

AGFA Corp. began a recall of IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving... on 2009-04-15. The reason FDA records is "User could modify a measurement's units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1435-2011
Status: Terminated
Initiated: 2009-04-15
Posted: 2011-02-25
Terminated: 2011-10-13
Recalling firm: AGFA Healthcare 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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: User could modify a measurement's units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM.
FDA 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 in commerce: 6 devices
Distribution: Nationwide distribution: USA including states of: IL, MT, NY, OR and SC.
Product codes and lots: Software Versions: RM 2.03, 2.04 & 2.06

Product code LLZ

K050228Class IIAgfa Heartlab CardiovascularHeartlab, Inc. / cleared 2005-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)