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Philips Healthcare Informatics, Inc. recalls Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication
Recalled August 27, 2014 · FDA recall Z-2252-2014 · Philips Healthcare Informatics
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. · FDA Class II
Units
109 units
Sold at
US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
Description
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.
Product
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Manufacturer(s)
Philips Healthcare Informatics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →