Intellispace Portal software Product Usage: Intellispace Portal is a… — Class II medical device recall Z-2000-2012
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2012-07-18, distributed nationwide. In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing m
| Recall number | Z-2000-2012 |
|---|---|
| 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 | 2012-05-22 |
| Classified | 2012-07-11 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-03-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, DE, DK, ES, FR, IL, NL |
| Quantity | 44 |
| Serial numbers | 79932, 79935, 79936, 79943, 80818, 80911, 80994, 81004, 81013, 81017, 81021, 81027, 81031, 81035, 81063, 81089, 81119, 81129, 81147, 81150, 81161, 81164, 81173, 81178, 81179 and 19 more |
| Model numbers | 881001 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2000-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.