Home / Recalls / AGFA Corp. / Z-2252-2012

Z-2252-2012 Class II Terminated

Recalled by AGFA Corp. — Greenville, SC

FDA device recall Z-2252-2012 was initiated by AGFA Corp. on August 9, 2012 and is designated Class II. Reason for recall: Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa's Medical Image Storage Devices - Media Purge Daemon (MPD) and Cardiovascular Purg… The recall status is terminated (terminated December 8, 2015). Affected quantity: 535.

Recall Details

Product Type
Devices
Report Date
August 29, 2012
Initiation Date
August 9, 2012
Termination Date
December 8, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
535

Product Description

AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device

Reason for Recall

Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa's Medical Image Storage Devices - Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS).

Distribution Pattern

USA Nationwide, Virgin Islands and Canada

Code Information

All software versions of DICOMstore in combination with Media Purge Daemon (MPD) or Cardiovascular Purge Services (CPS).

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-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)

FDA data resources