Home / Recalls / AGFA Corp. / Z-1662-2014

Z-1662-2014 Class II Terminated

Recalled by AGFA Corp. — Greenville, SC

Recall Details

Product Type: Devices
Report Date: June 4, 2014
Initiation Date: April 30, 2014
Termination Date: September 18, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: One

Product Description

IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

Reason for Recall

Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.

Distribution Pattern

Distribution to SC only

Code Information

Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - 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-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-1069-2013 Class II — IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates (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)