Philips Healthcare Informatics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2252-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 24, 2014

Date Posted: August 27, 2014

Recall Number: Z-2252-2014

Event ID: 68979

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.

Status: Terminated

Product Quantity: 109 units

Code Information:

IntelliSpace 4.4

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated