Home / Recalls / AGFA Corp. / Z-1069-2013

Z-1069-2013 Class II Terminated

Recalled by AGFA Corp. — Greenville, SC

Recall Details

Product Type: Devices
Report Date: April 17, 2013
Initiation Date: March 15, 2013
Termination Date: April 1, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2

Product Description

IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

Reason for Recall

Software design error in IMPAX CV 7.8 SU3

Distribution Pattern

Distribute in the state of FL and KY

Code Information

Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service

Other recalls by AGFA Corp.

Z-2081-2014 Class II — AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated f (June 6, 2014)
Z-1662-2014 Class II — IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical (April 30, 2014)
Z-0919-2014 Class II — IMPAX RIS QDOC 5.8 (January 8, 2014)
Z-0035-2014 Class II — IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archivi (September 19, 2013)
Z-1487-2013 Class II — AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated f (May 15, 2013)
Z-1070-2013 Class II — IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reportin (March 15, 2013)
Z-0970-2013 Class II — CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM (February 7, 2013)
Z-2252-2012 Class II — AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore (August 9, 2012)
Z-2184-2012 Class II — IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured report (July 27, 2012)
Z-2069-2012 Class II — IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component f (July 10, 2012)