FDA Device recall Z-1102-2013
Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-cli…
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-cli… by Philips Medical Systems Cleveland, citing 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 ana….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1102-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-12 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
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
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
Identifiers
| code_info | Model #881001, Serial #s: 79916, 79932, 79933, 79935, 79936, 79937, 79939, 79940, 79943, 80071, 80914, 80916, 80925, 8…Model #881001, Serial #s: 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, 81008, 81010, 81026, 81027, 81028, 81034, 81035, 81036, 81039, 81063, 81065, 81076, 81079, 81081, 81085, 81089, 81097, 81098, 81108, 81110, 81117, 81119, 81127, 81130, 81132, 81133, 81150, 81153, 81154, 81160, 81161, 81163, 81165, 81169, 81172, 81173, 81174, 81175, 81178, 81179, 81182, 81183, 81184, 81187, 81189, 81190, 81192, 81194, 81196, 81200, 82001, 82002, 82003, 82004, 82006, 82007, 82008, 82009, 82010, 82011, 82012, 82013, 82014, 82015, 82016, 82017, 82018, 82019, 82020, 82021, 82022, 82023, 82024, 82025, 82026, 82027, 82028, 82029, 82030, 82031, 82032, 82033, 82034, 82035, 82036, 82037, 82038, 82050, 82051, 82052, 82053, 82054, 82055, 82056, 82057, 82058, 82059, 82060, 82061, 82062, 82063, 82064, 82065, 82066, 82067, 82068, 82069, 82070, 82071, 82072, 82073, 82074, 82084, 82086, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1102-2013%22
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