FDA Device recall Z-2000-2012
Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagn…
- FDA Device
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagn… by Philips Medical Systems Cleveland, citing in the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode "edit contour" tool, the measurements are not recalculated causin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2000-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-22 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to remotely access the system from compatible computers on a network.
Reason
In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode "edit contour" tool, the measurements are not recalculated causing discrepancies with the lesion measurements.
Identifiers
| code_info | Model number: 881001; serial numbers: 80818, 85088, 81178, 82006, 82038, 81063, 82018, 79935, 81150, 81013, 81173, 8506…Model number: 881001; serial numbers: 80818, 85088, 81178, 82006, 82038, 81063, 82018, 79935, 81150, 81013, 81173, 85068, 79932, 79943, 80911, 82019, 81027, 85049, 85043, 82008, 81119, 81089, 85108, 85026, 85146, 80994, 81021, 81182, 81017, 85067, 81161, 81164, 79936, 85103, 81147, 85110, 85082, 81179, 81035, 85046, 81031, 81129, 81004 & 85104. |
|---|
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-2000-2012%22
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