Home / Recalls / AGFA Corp. / Z-0919-2014

Z-0919-2014 Class II Terminated

Recalled by AGFA Corp. — Greenville, SC

Recall Details

Product Type
Devices
Report Date
February 12, 2014
Initiation Date
January 8, 2014
Termination Date
February 28, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14

Product Description

IMPAX RIS QDOC 5.8

Reason for Recall

Patient name displayed (printed) on the Patient Report was the wrong patient name.

Distribution Pattern

CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada

Code Information

Software IMPAX RIS 58 and higher

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-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)