FDAFDA · Food and drugs·Recall number Z-2252-2014
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Published August 27, 2014 · Recall initiated: July 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Healthcare Informatics, Inc.
- Distributor
- US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
- Lot
- IntelliSpace 4.4
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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