Intellispace Portal — Class II medical device recall Z-1102-2013
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-04-24, distributed nationwide. Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS
| Recall number | Z-1102-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2013-02-12 |
| Classified | 2013-04-12 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CN, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HU, ID, IE, IL, IN, IT, JP, KR, LB, LV, NL, NO, PL, PT, RU, SE, SK, TH, ZA |
| Quantity | 313 units |
| Reason classes | software |
| Serial numbers | 79916, 79932, 79933, 79935, 79936, 79937, 79939, 79940, 79943, 80071, 80914, 80916, 80925, 80926, 80928, 80932, 80939, 80963, 80965, 80977, 80979, 80994, 80995, 81004, 81006 and 295 more |
| Model numbers | 881001 |
Product
Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.
Reason for recall
Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS integration. Philips was informed that when loading a study to an analysis application while using URL PACS integration configuration, after another study was opened by a review application, the Analysis monitor is updated with the study of the current patient, but the Review monitor conti
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.