Home / Recalls / AGFA Corp. / Z-0035-2014

Z-0035-2014 Class II Terminated

Recalled by AGFA Corp. — Greenville, SC

FDA device recall Z-0035-2014 was initiated by AGFA Corp. on September 19, 2013 and is designated Class II. Reason for recall: System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels. The recall status is terminated (terminated October 24, 2013). Affected quantity: 4.

Recall Details

Product Type
Devices
Report Date
October 30, 2013
Initiation Date
September 19, 2013
Termination Date
October 24, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4

Product Description

IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).

Reason for Recall

System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.

Distribution Pattern

Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.

Code Information

N/A

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-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-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