Home / Recalls / Philips Healthcare Informatics, Inc. / Z-2252-2014

Z-2252-2014 Class II Terminated

Recalled by Philips Healthcare Informatics, Inc. — Foster City, CA

Recall Details

Product Type
Devices
Report Date
August 27, 2014
Initiation Date
July 24, 2014
Termination Date
February 11, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
109 units

Product Description

Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.

Reason for Recall

A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.

Distribution Pattern

US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.

Code Information

IntelliSpace 4.4

Other recalls by Philips Healthcare Informatics, Inc.

  • Z-2338-2020 Class II — IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be use (April 19, 2019)
  • Z-1646-2014 Class II — Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 (May 5, 2014)
  • Z-0269-2014 Class II — Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a so (October 14, 2013)