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Recall Observatory FDA recall evidence

Device product

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

Z-2252-2014

July 24, 2014

Class II

Product summary

Firm
Philips Healthcare Informatics, Inc.
Event
Event 68979
Status
Terminated
Classification
Class II
Quantity
109 units
Official record key
device-enforcement:Z-2252-2014

Official wording

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.

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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    problem was detected in the Philips IntelliSpace PAC 4.4 software