Z-2112-2010

IMPAX CV Results Manager/Results Manager Administration Tool

Name: Z-2112-2010 IMPAX CV Results Manager/Results Manager Administration Tool
Creator: AGFA Corp.
Published: 2010-06-11
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2010-06-11 / Terminated

FDA source

AGFA Corp. began a recall of IMPAX CV Results Manager/Results Manager Administration Tool on 2010-06-11. The reason FDA records is "Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2112-2010
Status: Terminated
Initiated: 2010-06-11
Posted: 2010-07-29
Terminated: 2013-07-02
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX CV Results Manager/Results Manager Administration Tool
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators.
FDA root cause: Other
Action: A letter was sent to the consignee on 6/11/2010 indicating what steps would be taken by Agfa concerning the problem. The letter also included a feedback form which was to be returned to Agfa. The recall was expanded and a "URGENT SAFETY NOTICE" was sent to each additional consignee on January 25, 2012. The letter described the potential issue and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood has been requested from the additional consignees.
Quantity in commerce: 358
Distribution: AK, AZ, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI and Canada
Product codes and lots: Model No. L9M2100; Software Versions RM 2.08.12.00.00. All versions of the CV Reporting (RM) are now affected.

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)