Philips Healthcare Informatics, Inc. Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Brand
Philips Healthcare Informatics, Inc.
Lot Codes / Batch Numbers
IntelliSpace 4.4
Products Sold
IntelliSpace 4.4
Philips Healthcare Informatics, Inc. is recalling Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measuremen due to 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 expo. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026