Home / Recalls / AGFA Corp. / Z-1070-2013

Z-1070-2013 Class II Terminated

Recalled by AGFA Corp. — Greenville, SC

FDA device recall Z-1070-2013 was initiated by AGFA Corp. on March 15, 2013 and is designated Class II. Reason for recall: Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) syste… The recall status is terminated (terminated January 9, 2014). Affected quantity: 26.

Recall Details

Product Type
Devices
Report Date
April 17, 2013
Initiation Date
March 15, 2013
Termination Date
January 9, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
26

Product Description

IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.

Reason for Recall

Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.

Distribution Pattern

Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.

Code Information

Model # L9M21000. Software versions: IMPAX CV 7.8, 7.8 SU1, 7.8 SU2 and 7.8 SU3, IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL

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-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