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Z-2184-2012 Class II Terminated

Recalled by AGFA Corp. — Greenville, SC

FDA device recall Z-2184-2012 was initiated by AGFA Corp. on July 27, 2012 and is designated Class II. Reason for recall: Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report. The recall status is terminated (terminated January 13, 2015). Affected quantity: 280.

Recall Details

Product Type
Devices
Report Date
August 22, 2012
Initiation Date
July 27, 2012
Termination Date
January 13, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
280

Product Description

IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

Reason for Recall

Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Canada

Code Information

Model # L9M2100 - All Software versions of IMPAX CV Reporting

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-1069-2013 Class II — IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates (March 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-2069-2012 Class II — IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component f (July 10, 2012)

FDA data resources