Philips brand IntelliSpace PACS 4 — Class II medical device recall Z-0269-2014
Terminated recall by Philips Healthcare Informatics, Inc., reported 2013-11-20, distributed nationwide. Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issu
| Recall number | Z-0269-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Informatics, Inc., Foster City, CA, United States |
| Recall initiated | 2013-10-14 |
| Classified | 2013-11-13 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2014-06-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 71 units |
| Reason classes | software |
Product
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.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.