Device product
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Z-2252-2014
Product summary
- 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
problem was detected in the Philips IntelliSpace PAC 4.4 software