Recall Z-2252-2014— Philips Healthcare Informatics, Inc.

Name: FDA recall Z-2252-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-24

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Informatics, Inc., initiated 2014-07-24, terminated 2016-02-11. It names one FDA 510(k) clearance: K111804. Product: Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.. Reason: 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..

Recalling firm: Philips Healthcare Informatics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-24
Terminated: 2016-02-11
Firm location: Foster City, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K111804 — INTELLISPACE PACS 4.XPhilips Healthcare Informatics, Inc.·cleared 2011-07-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.