Philips IntelliSpace PACS 4.4 Software Recall for Data Integrity Issues
Philips is recalling IntelliSpace PACS 4.4 software because a defect may cause incomplete patient data to be exported, potentially affecting diagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential diagnosis on incomplete data.
Plain-English summary
Philips Healthcare Informatics, Inc. is recalling 109 units of the IntelliSpace PACS 4.4 image management system. The system is used for digital image processing, measurement, communication, and storage. The recall is due to a software problem where patient information in the DICOM header may not update correctly before export.
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 be exported. This creates a potential for diagnosis based on incomplete data. The affected units were distributed in the US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and United Kingdom.
Healthcare facilities using this software should contact Philips Healthcare Informatics, Inc. for further instructions on how to address the issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
- Manufacturer
- Philips Healthcare Informatics, Inc.
- Category
- Medical Device — Software
- Affected units
- 109
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- IntelliSpace 4.4
Distribution
Distribution scope not specified by the agency.
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