Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips brand IntelliSpace PACS 4.4 Recalled by Philips Healthcare Informatics, Inc. Due to Philips Healthcare became aware of a software problem...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Healthcare Informatics, Inc. directly.
Affected Products
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.
Quantity: 71 units
Why Was This Recalled?
Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. The missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Healthcare Informatics, Inc.
Philips Healthcare Informatics, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report