Z-0212-2012

IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a...

Name: Z-0212-2012 IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a...
Creator: AGFA Corp.
Published: 2011-06-06
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2011-06-06 / Terminated

FDA source

AGFA Corp. began a recall of IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular Information system providing image... on 2011-06-06. The reason FDA records is "Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0212-2012
Status: Terminated
Initiated: 2011-06-06
Posted: 2011-11-18
Terminated: 2014-05-08
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR).
FDA root cause: Pending
Action: The firm, AGFA HealthCare" sent an 'URGENT FIELD SAFETY NOTICE" dated May 27, 2011 via FED-EX by June 6, 2011 to all customers using the affected product. The letter describes the product, problem and actions to be taken. The customers were instructed to distribute this information within their facility to all those who need to be aware and to complete and return the attached FEEDBACK FORM via fax to 864-421-1668 or email to [email protected]. AGFA will provide software corrections to all affected sites and will contact the customers to schedule the analysis and provide any corrections if required. If you have any questions about this matter, please contact your local Agfa HealthCare Service at 877-777-2432.
Quantity in commerce: 280
Distribution: Worldwide distribution: AK, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WV; and country of: Canada.
Product codes and lots: Software Versions - All DICOMStore Version 2.04.44 and earlier

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)